Adapted from episode 88 of The Perfect Stool podcast and edited for readability with Shaina Cahill, PhD, neuroscientist and Director of Medical Communications and Affairs at Novel Biome.
Lindsey:
So why don’t you start by telling us about Novel Biome and the work you’re doing there with fecal microbiota transplants?
Shaina Cahill, PhD:
Yeah, so at Novel Biome, we focus on providing high quality, medically-supervised fecal microbiota transplantation (FMT). Our focus is specifically on children or adults with autism spectrum disorder though we do treat people outside of that. Adults that have other conditions that can be helped with FMT. We have four treatment locations in Hungary, Panama, Mexico and Australia. We’ve expanded these to try to reduce the stress and burden it is to try to access this level of treatment. We’ve been around since 2019, with a focus and being Novel Biome. And this came about – two studies were published in 2017, and 2019, by Dr. James Adams, his group out of Arizona State University.
Lindsey:
That we’ve had on the podcast twice.
Shaina Cahill, PhD:
Yeah. And so his work, I think, really stimulated more interest in the possibilities of FMT with autism. And so parents started to reach out about how FMT might be a good fit for their children. And that has just expanded from there. And we’ve focused in on on ASD, because we think that the research to date has been so valuable, but as well, children with autism spectrum disorder are three times more likely to have GI issues. These GI issues really impact quality of life and there seems to be some correlation between the severity of GI symptoms and the severity of ASD-related behaviors. And so there’s a good groundwork of research that’s been around for a long time tying gastrointestinal issues to children with autism. While this research on FMT is new, there’s been an understanding that there is a GI component for not all children with autism, but a good proportion of children with autism. So that’s what led us to do what we do.
Lindsey:
Yeah. And so, Dr. Klopp is from Canada originally?
Shaina Cahill, PhD:
Yes.
Lindsey:
Where’s your clinic there?
Shaina Cahill, PhD:
We don’t treat in Canada. In Canada, we’re a biomanufacturing company for export and working with Health Canada. Health Canada doesn’t want FMT to be a treatment that’s accessible right now to Canadians, so when working with them, we don’t advertise. We don’t treat Canadians and our website is not even accessible in Canada. We primarily just work as a biomanufacturer and that’s in accordance and following all the rules with Health Canada. And they’ve evaluated and looked at everything and we’re working towards getting a drug establishment license, which then further solidifies our export processes as a drug as well.
Lindsey:
And then your clinic in Mexico – that’s in Tijuana, right?
Shaina Cahill, PhD:
No, it’s in Rosalia.
Lindsey:
Is it near California though?
Shaina Cahill, PhD:
Yeah, so it’s like driving distance from the US border, but that’s our closest, I guess, to the US site and that one’s been around for the longest. That was our first site and then we’ve kind of expanded from there working with clinics that have the capabilities and the understanding of FMT. We supply product and a protocol for them, and they provide the treatment there.
Lindsey:
And so why the focus on autism in particular? Does Dr. Klopp have any particular relationship with that or was it more just because of the patients asking about it?
Shaina Cahill, PhD:
It’s the relationship with the patients asking, as well as having a good groundwork for why FMT would work. The research today has been really good, and then that understanding of those GI symptoms, those are there. And so we know that there’s a good groundwork of support for why this would work.
Lindsey:
And what kind of GI issues do children with autism typically show?
Shaina Cahill, PhD:
Kind of runs the gamut. A lot of the major ones are a mixture of constipation and diarrhea, which oppose each other, but those tend to be the two. Bloating and abdominal pain seem to be the ones that we see the most in the literature. Those are the consistent ones that come up.
Lindsey:
And these aren’t just cases of SIBO that could be treated in a different way, or do you do deal with other potential treatments prior to going to FMT?
Shaina Cahill, PhD:
Yeah, so part of our protocol starts with a personalized pretreatment that’s done by a physician’s assistant. They go through basically what’s currently being treated, what tests have been done, what other tests should be done and what types of medication for before going into FTM. Sometimes we’ll find out that there are larger mold issues and things like this, and then we’ll hold off on FMT get all of those treatments done, so that the gut is ready to take on FMT. That’s a case by case and every case is different. So we make sure that we tackle any issues that could be solved before going into FMT.
Lindsey:
Okay, And so what percentage of your practice would you say is children with autism versus other issues?
Shaina Cahill, PhD:
That’s a good question. I would say probably 90% is autism and most of those are going to be children with autism, not to say that children with autism are only coming for autism. So we also see, some parents are really highlighting those gastrointestinal issues, or IBS or IBD, as well as, seeing that their child also has autism. It’s not always just that parents come in, they’re like, “We have an autistic child, we think an FMT will help.” It’s often that, well, we have these like gastrointestinal issues that are causing a lot of issues. We’d like to tackle that and if we see outcomes with autistic-related behaviors, that’s also great. What we try to instill is that the first outcome is always going to be GI, but we see these secondary outcomes with autistic-related behaviors. So it’s not that this is specifically a treatment for autism, it’s tackling one of the symptoms, which seems to be GI, which then leads to the secondary changes, which we don’t understand at this point. The research is not there to understand why these changes are happening, but it is showing that there’s a relationship between the two.
Lindsey:
Well, we can get more into the results in a minute, but first, I want to ask about your donors. So who are your donors?
Shaina Cahill, PhD:
So we have really stringent donor screening characteristics that we look for. There are published standards. There’s about nine of them that are out right now and what we do is we look at what those initial screenings are. And then we have our own subset that we also look at on top of that. We’re looking for all of our donors not having taken antibiotics in their whole life, having been vaginally born and breastfed. And we know these things are the pillars of creating a stable gut microbiome from the beginning. And then of course, we’re looking at their diets, as well as their exercise habits. We look at a wide variety of both in them and in their family history of any disorders that we think could be or might soon be understood to be tied to the gut microbiome, to try to reduce any transfer. So we screen our donors, and that leaves us with very few donors that we can even use and then outside of that their blood and stool is tested. That’s done regularly every three months to make sure that there’s nothing there. And so, like everywhere, we find donors that meet our requirements, and we use them as long as they’re willing to donate.
Lindsey:
Is there a an upper limit for age with your donors?
Shaina Cahill, PhD:
Right now, we don’t have any donors over the age of 30. I mean, right now, in the research, they’re saying there shouldn’t be huge shifts in the gut microbiome until somewhere in the 60s, 70s range, but most of the published cut offs are around 60. And we want to keep ours under that because we do know that there are changes and not just changes in the gut microbiome, but changes in how people live as they get older, which then impact that microbiome. So we’re trying to stay on the cusp of not having any of those issues. So right now, we don’t have anyone over the age of 30.
Lindsey:
Is that the exclusion age or is that just by chance?
Shaina Cahill, PhD:
By chance. Right now, our exclusion age – in our written documents, I think is 40. So that’s the same range, but we just want to ensure because we know that age impacts it. We’re still really understanding that and when that shift happens, There’s a whole bunch of issues in the aging gut microbiome research that I could go on for days about. So I think we’re just trying to stay on the cusp of what we know for sure, versus getting into ages where there might be impacts. With FMT, the more you can control what is going on with your donors, the better, because we want to ensure what we’re giving patients is consistent and safe. And so the more we can control what the donor is going to pass on, the better it is for the patients.
Lindsey:
And do you allow your patients to see the donor screening questionnaire that you use with their donors?
Shaina Cahill, PhD:
Yeah, so any patient or anybody that wants to kind of understand that, we can give that Anyone that goes through treatment can see the reports of the blood and stool screening and stuff like that from the donors. But that just we’d have to be somewhat mindful, because it’s their health records. So we can give a general understanding of what the donors have that they’ve passed all of these screenings, but we can’t give everybody “Here are these people, this is where they live, this is everything they do,” because we also do protect the donors themselves. So there is some information we can provide and there’s some information we just can’t provide, but we try to be as transparent as possible, where privacy allows us. Our donor screening and all that stuff is something that is readily available for anyone that asks. It’s not on our website, because it’s a very long –
Lindsey:
Could it be something that I could share with my audience? Would you
be willing to –
Shaina Cahill, PhD:
Yeah, I can send the questionnaire to you. It’s a couple pages long, but yeah, that’s easy enough.
Lindsey:
I can post that in my show notes.
Shaina Cahill, PhD:
Yeah
Lindsey:
Cool. Can your patients see the pictures of the stool prior to processing?
Shaina Cahill, PhD:
I can’t guarantee you that anyone’s ever asked. We use the Bristol Stool Chart and there’s a cut off where if stool don’t fall in these two categories, we don’t use it.
Lindsey:
Three and four?
Shaina Cahill, PhD:
Yes, but outside of that, that’s all there is. I don’t know if we take pictures of it. We have a lab manager who does all of those things. But I highly doubt –
Lindsey:
But if someone asked they might be able to?
Shaina Cahill, PhD:
Yeah, I think if someone really needed to, but I think what it’s like is: this is the categories they fall into and, and anything that falls out of that is always documented. Of course, that donor is not used and then we categorize that donor until they’re back into that time period and figure out what could have happened, as well. So that we want to make sure we’re only using the best and so that’s not part of my job, but part of hers.
Lindsey:
Do patients get stool pretty much from one donor or is it mixed together with multiple donors?
Shaina Cahill, PhD:
We usually use at least two donors for patients. And we just want to make sure that the goal here is that like, it’s diversity, ensuring that you get everything you can by using two donors. We actually suggest people rotate back and forth between what donor they’re taking, so that we can get the best benefits. There’s some disagreement and some agreement about using multiple donors versus one. But most of what we’ve read in the literature seems to support the use is there’s a benefit to having multiple donors versus just a single donor. So we’re hedging our bets with that.
Lindsey:
And how do you process your stool for transplant?
Shaina Cahill, PhD:
That would be a good question for our lab manager. I’ve toured her lab, but I have not watched her process anything because she’s very picky about cleanliness and who’s around when she’s doing stuff, which I appreciate wholeheartedly, but that would be something that she would know more about than I do.
Lindsey:
Well, maybe you could ask her and I could just put a paragraph in the show notes afterwards about what the process is?
Shaina Cahill, PhD:
Yeah, we have standardized procedures, so I don’t think it’d be hard for her to pull, but that’s not something I know anything about that off the top of my head.
Lindsey:
And so what is your protocol for preparing the recipient for the transplant? Do they take antibiotics?
Shaina Cahill, PhD:
Yeah most of the time, everyone is going to take an antibiotic, but it’s individualized. So that’s part of our process. We work with parents and their children to see what is necessary for them to be prepared. I think we’re as a field starting to really understand the importance of pretreatment. There’s actually been some new studies that have come out and said, “In cases where antibiotics were done before FMT, there’s more success there.” So that is one of our standards, but it’s not consistent and not everybody takes antibiotics. That’s also dependent on the comfort levels and where we think some parents don’t feel comfortable, we use alternatives to antibiotics. It’s completely individualized for the person, so there’s no like, “Here are the three steps we use for everybody.” Because no person fits perfectly into a puzzle every time, we alter it depending on them.
Lindsey:
Okay, so if you didn’t use antibiotics, would you use herbal antimicrobials?
Shaina Cahill, PhD:
From my understanding that has been done. I mean, consistently, it is almost always antibiotics. For people who don’t feel comfortable, we use a natural alternative to an antibiotic.
Lindsey:
Is there a particular antibiotic that you prefer?
Shaina Cahill, PhD:
I think it’s normally vancomycin, but I can’t be 100% sure.
Lindsey:
That’s what I’ve heard from I think, Dr. Adams.
Shaina Cahill, PhD:
Yeah.
Lindsey:
Okay and how long is the course of treatment?
Shaina Cahill, PhD:
Our protocol, we do a two-day, high-dose, and that’s going to be at one of our treatment centers. The total protocol is 16 weeks of FMT treatment.
Lindsey:
Daily?
Shaina Cahill, PhD:
Yeah, daily for 16 weeks. We do that, because there seems to be a huge impact on the amount of time that treatment is done. Studies that have done four weeks, versus something like Dr. Adams’ study, which did eight, you see significant improvements. We’ve extended ours and we see more consistent outcomes and we think part of that is because of that kind of extended treatment period.
Lindsey:
And are these all being done by retention enema or are you doing capsules?
Shaina Cahill, PhD:
Yeah, so at our treatment centers, you can do either an enema or loading oral dose, and that depends on the child or the person getting treatment. Some children can’t take capsules, so they will take a retention enema. When they go home, for kids that can take capsules, they’ll continuously take the capsules. Anyone that can’t swallow the capsules, we have an oral powder, which can be mixed with water, juice or milk. They can take it that way versus having to take a capsule.
Lindsey:
Okay, so it’s highly purified the way that Dr. Adams’ stool is – to the point where it doesn’t resemble fecal matter anymore I assume.
Shaina Cahill, PhD:
Yeah, so it’s odorless, tasteless and colorless.
Lindsey:
Just the bacteria.
Shaina Cahill, PhD:
Yeah. And so that allows us to provide an at-home version of the treatment for kids that can’t take capsules. And that’s really common in smaller kids. That allows a comfort for that and it’s easy to mix it into something they would normally drink anyways.
Lindsey:
So it’s really just a fancy probiotic pulled from someone’s stool when push comes to shove.
Shaina Cahill, PhD:
It’s an engraftable, I guess. Because it’s a higher diversity, and you’re getting everything.
Lindsey:
Including the anaerobic strains. Does it have to be refrigerated?
Shaina Cahill, PhD:
For extended periods. So we suggest four degrees storage, because of what we’ve seen. So far, that’s been done, and we’re doing our own stability studies to get a better understanding, because there hasn’t been a ton done. But when it’s at four degrees, when it’s been partially freeze dried, we know that it’s good for up to about a year. So we suggest keeping it in the fridge and then keeping it at a consistent temperature because those temperature variations can cause some some issues as well. Yeah, and everything that’s in your gut microbiota aren’t bacteria. There’s a whole host of things, right. So you’re
getting all of that and with a probiotic, it tends to be concentrated on a couple of strains. And we know that probiotics don’t engraft. So they’re good while you’re taking them, not good long term. There is a difference. I think because it’s purified and partially freeze dried, you’re looking at a more stable and something that can be used for a longer period of time. So there are differences. And as FMT is coming along, we’re seeing these improvements. Oral capsules weren’t a thing a couple of years ago. That’s really kind of changing what FMT looks like, and its accessibility. But as well now being able to partially or fully freeze dry it, now it’s becoming more shelf stable. The life, the longhood, the longness of it, how you can store it and how it’s able to be stored and then shipped and stored in someone’s house for longer periods of time makes it an easier product to have.
Lindsey:
So is that four degrees a typical – this is Celsius right?
Shaina Cahill, PhD:
Celsius, yes. Standard fridge temperature is the –
Lindsey:
Which is I think somewhere around like 40 degrees Fahrenheit or something like that.
Shaina Cahill, PhD:
Yeah.
Lindsey:
Okay, what gut health conditions, does the research say are most positively impacted by FMT?
Shaina Cahill, PhD:
It’s a wide variety. And we’re still learning. I think the biggest thing to say is, currently, it’s only approved for treating recurrent C Diff.
Lindsey:
In the US.
Shaina Cahill, PhD:
And the outcomes of that are magical. Because it’s been so safe and consistent, research is growing in other areas. Across the board, we need more randomized clinical trials. We need larger clinical trials and we need more patients to see consistency. I think that’s the first statement to make across the board. For Irritable Bowel Disease, there have been a number of positive studies. While the results aren’t what we’re seeing in C. diff, which is like 90%, it seems to be consistently around somewhere between 30% improvements.
Lindsey:
Irritable bowel syndrome, or inflammatory bowel disease?
Shaina Cahill, PhD:
Irritable bowel disease, and there’s no consistency. There’s been 10 studies done in Crohn’s and –
Lindsey::
We’re talking about Crohn’s and Colitis (or inflammatory bowel disease).
Shaina Cahill, PhD:
Yes. And so that’s around about 30%. But because diseases that fall under IBD are inflammatory in nature, and they’re cyclical, I think that’s what we’re seeing in the research. When people aren’t in an inflammatory state, their response is different than when they are. So that’s complicating the research a little bit. There are certain disorders where when you treat will also matter. There’s some really great, new clinical trials coming out for Parkinson’s disease – the stuff that’s been done to D has just been case studies and preclinical, which are promising and I think there’s four clinical trials coming that are currently ongoing for Parkinson’s disease. There’s a couple for MS, multiple sclerosis, Autism Spectrum Disorder, of course, we’re seeing clinical trials and growth and research there. There’s been some research looking at cancers. There are some steps specifically for cancer, but a lot of the research right now is looking at treating side effects of cancer treatments. The biggest beacon we’re seeing is people who are getting stem cell treatments or bone marrow treatments, because of what has to be done to prep the body to get those treatments, they’re actually finding using either FMT or autologous fecal microbiota transplantation, which is using someone’s own stool. They take the stool before they get any of the prep done for the stem cell treatment, and then do the FMT. They actually see that improves both uptake and any issues with graft versus host. But as well, it just makes the process more enjoyable or more easily reduces side effects. IBS is another one that they’re showing studies in, which seems to be a little bit more consistent than IBD, which I think is like 40 to 50% improvement. There’s not a ton of studies. And again, there’s more coming. The clinical trials are growing in this area. But those are kind of the main areas we’re seeing a lot of growth and research.
Lindsey:
Okay, cool. It was a good summary. And so I know that there was some controversy surrounding Dr. Klopp and his use of FMT, so can you can you explain a little bit about what’s going on with that?
Shaina Cahill, PhD:
Yeah, so we’re still in the midst of it. It’s been going on for too long. It started in 2020, where the main issues came out, and a lot of it was around manufacturing standards, the use of FMT in children with autism spectrum disorder, and advertising. So we’ve completely revamped how we advertise. And that’s something that we’re consistently changing as we enter new countries. We’re working with external help with that, because none of us are marketing people. We’ve been learning about that, as well as in Canada, worked with
Health Canada, decided to not advertise. We don’t treat Canadians so that’s been part of the change, as well, for manufacturing standards. We’ve had Health Canada in. They’ve looked at our procedures, they’ve looked at our laboratory. For us, Health Canada’s the governing health body here, similar to the FDA in the States. We’ve been investigated and cleared of any deviations from acceptable procedures. We have a beautiful and wonderful lab. I am jealous of it. I worked for very long time in labs, and it is very, pretty clean and nice. I wish that’s where I worked previously.
I think that we’re working with governing health bodies, making sure we’re meeting all their requirements. And that’s all we can do. Unfortunately, none of those things have been picked up by the media, but everything else seems to continue to live there. We’ve reevaluated how much information we put out into the public. We didn’t put a lot out there, so we completely revamped our website. We’re more transparent about our donor screening and our screening that we do to blood and stool. We also have really put our time into providing education. What is FMT and why is it important? There’s not a lot out there and some of the research that is out there is really hard to digest. We’ve taken it upon ourselves to try to provide easily-accessible education so people can understand what FMT is, and what we know about it right now. How we’ve decided to tackle the negative attention we’ve gotten, is by evaluating what we were doing and why this could have happened. Our first thought was that while we’ve always been science driven, we weren’t being transparent enough about that. And then when it comes to manufacturing, we’re on the up and up. We’ve been evaluated by everyone that
matters for that and that’s all we can do.
Lindsey:
And I know Dr. Klopp’s credentials were threatened. Has that been resolved?
Shaina Cahill, PhD:
We’re waiting for for the decision on that.
Lindsey:
He currently still has them.
Shaina Cahill, PhD:
Yeah, so he’s still a naturopathic doctor.
Lindsey:
Just wanted to make sure. Okay, so I know you were tracking your results internally. Are you tracking them with regard to the particular donors, or just in general?
Shaina Cahill, PhD:
Yes, right now we, internally, we collect a number of measures from our patients. So before, during, and after FMT, to monitor changes what we’re looking at across, we look at stool. We also look at GI symptoms, and then we look at a number of measures specifically associated associated with ASD. We also have a new observational study with Biohm that we’re looking at. The first thing is looking at the gut microbiome of children with autism to get a better understanding of what are the markers and what’s different about their gut microbiome? The second part is, we understand that there is an importance to donor and recipient matching. I think, as the field grows, we’re seeing that more and more so in this study, we’re measuring our donors as well as measuring our patients, but then measuring what the interactions and what the changes are based on how similar or different those gut microbiomes are, and what the outcomes look like. So we’re in the process of collecting data to understand the donor-recipient relationship, as part of our efforts to increase the research and data that exists.
Lindsey:
Have you had positive results or negative results of certain donors that have led you to no longer retain them?
Shaina Cahill, PhD:
No, we haven’t had any donors that we’ve not used. To become a donor is so stringent, I think standards based on what’s been published, about 50 to 80% of people don’t pass the initial screening. Our screenings are in even higher levels than that, because in a lot of cases, it’s like you haven’t had antibiotics in three to six months. We – just you’ve never had them. And we tend to go to the extremes for a lot of things to ensure that we’re not missing anything. So the number of donors you even get just past that initial screening s so few and then on top of that their blood and stool is screened and then regularly screened. The likelihood that a donor has something that’s specifically not good is very low. And then we retain our donors as long as possible, because they’re really hard to replace.
Lindsey:
Right? Are they coming in every day? Basically dropping off their samples? And these are all in Canada, right?
Shaina Cahill, PhD:
Yes. So you have to be close to our site. So we’re in Chilliwack, BC, so they would all be within easy driving distance.
Lindsey:
So let’s get to the kinds of success you’ve seen with FMT and ASD and other conditions.
Shaina Cahill, PhD:
Yeah, so I’ll focus just on ASD because that’s where we have the most. I don’t like to make conclusions about small things. But we do we know that the process is like, we know that when children take antibiotics, we do see changes in their behaviors and, when you start FMT, there’s always a period of time where you see changes like increases in hyperactivity, increases in some behaviors. We see that basically, once we think that the gut microbiome has started to kind of engraft and become part of the system, you start to see improvements. It varies, but most of our patients say between between the first and the third month, they start to see consistent improvements. in the first couple of weeks, it’s just the change. I think, a mixture of wiping out the first gut microbiome and engrafting the next one, you see a lot of changes. Before you see consistent improvements, we see those going into that one to three month mark. GI symptoms seem to be consistently improved and that’s supported in the research. The ASD-related improvements do vary, but a lot of them are the improvements in eye contact. Improvements in speech seem to be something we see consistently and then consistency is in behaviors. A reduction in stimming behavior and a reduction in aggressive behavior seem to be ones that we see more consistently, but we’re in the process of collecting more consistent data over longer periods of time, so that we can start. Our goal is to publish it so that it’s readily available for people to see, so that we have consistent data points that are done regularly and done by validated measures. We were only originally using one validated measure. We’re now using three and we’re also looking at quality of life changes, which is something we want to have a consistent measure on. These are all things that we’ve added in the last six months, so we’re still collecting data. Because our process takes so long, we have a 16-week treatment period. We’re just now starting to get people through their end of FMT and their follow-up. So we’re a little bit further away from having conclusive statements, but from what we’ve seen previously, and what’s been reported from parents, results are consistent. People do see changes and improvements in their quality of life, but we want to have objective measures across the board, because everybody’s perception of these things is different. We want to make sure that it’s validated.
Lindsey:
How long does that take? And are you also recommending diet changes or supplements? In addition?
Shaina Cahill, PhD:
Yeah, so we do consultations with our physician’s assistant at the beginning, in the middle of FMT and at the end of FMT. That’s used to monitor what changes are happening, answer any questions, but as well as put in place any supplements or anything that should be added to help stabilize that gut microbiome and feed it. We also work with parents by trying to provide them with information around what things in the diet are important, and to make sure that they understand how what you eat feeds that gut microbiome. And so you have to diversify the gut by diversifying the diet and ensure that you’re feeding every aspect of this new bacterial body that’s there. We try to provide them with information and we’re consistently researching what the most important things in the diet are for the gut microbiome. We always suggest you should eat 50 different foods every week. We try to help parents get to that point. Kids with ASD often have a lot of issues with certain specific foods. So what creative ways are there to increase what they’re eating and what foods to focus on first. So that’s all stuff that we provide, as the process goes along and try our best to answer their questions. It ranges from like, “Is this pack of lettuce better than this, because it has more things,” to, “What types of smoothies are better,” to ensure that they have the most support we can give them. It is a huge shift, but the more you can do that, the better that gut microbiome will be. That’s the goal – to make a stable, healthy gut microbiome once it’s been transferred.
Lindsey:
And what supplements do you typically recommend?
Shaina Cahill, PhD:
I cannot tell you off the top of my head, mostly because it’s individualized. I’ve said that before, but it really is like each person, depending on what they were taking before they started. Some people come to us with a very short list. Some people have a very long list of stuff that their children are already taking. And some of those are like, “We have to take some of these off.” Some of them that we add on for other people. So it really depends on each child and where their starting point is and where they end up as they go through the process.
Lindsey:
And is there any case study that you could highlight or any individual child that you could talk about, just to just to get a an idea of what’s going on?
Shaina Cahill, PhD:
We have done interviews and stuff with parents like what improvements they’ve seen, but it really is dependent on where the children started. We treat children that start as being categorized as mild, as well as being characterized as severe. Those journeys look completely different, because of what’s going to change and what the driving force was. A lot of parents consistently say that they’re able to go about each day easier. Some of the things we talk to parents about at the beginning of their journey, and the first things that start for them is being able to get their child to have their coat on and into the car has now been less of a battle. For some people that’s where it starts and it continues to go forward. Being able to have a conversation, for them to feel like their child understands them and to be able to integrate more easily. For a lot of parents too is that everyone can eat the same food at dinner. And so these are changes that happen throughout the process that make huge impacts for quality of life for both the child and the family. And those continue to go. So it’s not always specifically about different changes in their diet, or in specific ASD-related behaviors like stimming, or eye contact or aggression. It’s also about those changes all coming together to make life easier. And I think that’s what we hear parents talk about the most is just the changes in their day to day lifestyle, and how things have become easier. So I think outside of what you expect to see in changes in ASD-related behaviors and GI symptoms, it’s those changes in quality of life, as well, that a lot of parents talk about.
Lindsey:
And so if somebody is coming to you for something else, like IBD, or IBS, is it a much shorter protocol?
Shaina Cahill, PhD:
From what I understand it’s average is between two to three or two to four months, depending on the person, what their journey looks like and where they’re starting. Our process starts always with a call and you talk to someone on our team, and we get a better understanding of why you think FMT would be a good fit, what your current situation looks like, and that starts the process of, “Is this a good fit for you or not?” And then you meet with a physician’s assistant to talk about what issues you’re having, what kind of reports you have, from your doctors to see where are we right now and where do we want to be? That determines the length of treatment, and how we approach your pre-treatment and your post-treatment as well.
Lindsey:
And roughly how much does this cost for ASD or for shorter conditions.
Shaina Cahill, PhD:
So for our ASD protocol, which includes meeting with a physician’s assistant, meeting with a behavioral or clinician who does assessments, we use the CARS assessment, as well as the treatment, and treatment at our sites is $14,300 USD. And then that’s kind of our standard. If you’re coming to us with something else that would be dependent on the length of treatment, and if it would all be at home or if you would be coming to one of the sites as well.
Lindsey:
So it is possible to just do it at home?
Shaina Cahill, PhD:
Depending on who you’re referred by. We have patients that come to us for C diff and so their gastroenterologist or their doctor will send us a request form and then we can send out just an at-home treatment for them to do.
Lindsey:
Can you send out at-home treatments for people in the US?
Shaina Cahill, PhD:
Yeah, so for C Diff, we have done that.
Lindsey:
But not for IBS or IBD?
Shaina Cahill, PhD:
That would be something that you would talk to the team about, because it would depend. For some people, having those loading doses will be a requirement. It would depend on where they are and what works and if at home is the best thing then we work with them and their doctors to ensure that we can get it to them at home.
Lindsey:
But they have to come in via one of your clinics in those various countries.
Shaina Cahill, PhD:
Or they can have their doctor submit a request form for treatment and we can send it directly to them. There’s some flexibility but it would have to come as a request from a physician. That’s the way that we can do it.
Lindsey:
Okay. Because I know that obviously, in the US right now, it’s only FDA approved for recurrent C Diff. I’m curious how that works. Just because if a physician requests it, does it somehow get around that rule?
Shaina Cahill, PhD:
I don’t know. So all of our stuff has been done for C. Diff. I think for all of our secondary patients, it would depend on on their case, and that stuff I don’t know about, because I don’t work directly with patients. I have a PhD, not an MD, so they keep me away from all of the people. But we know we do have cases where, we work with them to try to make sure that the process is something that can be handled, but I’m not sure how it works. And it may be country specific, because for each country, the rules for FMT are different. And we treat globally. So that’s why we always say, talk to the team, they will figure out where you are, and what the rules are, and then how to kind of approach that.
Lindsey:
Like you might be able to refer them to a doctor in their area?
Shaina Cahill, PhD:
Yeah. And if they’re in a different country where FMT is regulated differently than it is in the US, then the procedure would be different, because it always depends on what the health authority there’s requesting and what the procedures are. So, we treat in the US, but we don’t treat all in Canada, but we have patients in Europe and South America, everywhere. So it’s dependent on where they’re located. I think the procedure depends, and that’s why I always say, the best thing to do is book a call and talk with us. And we can work through all of that, because there is a lot of legality and rules around where you’re located and how treatment can be done. So it’s hard to make a singular statement, I guess. Yeah.
Lindsey:
Is there anything else you would like to share before we finish up?
Shaina Cahill, PhD:
I think that if you have questions about FMT, or if you think FMT might be a good fit for you, book a call and ask questions, and see where it is, because it is something that’s growing, and we’re understanding more and more about it. But I think for every person, it’s going to be different. And our goal is to ensure that you’re informed, and that you have an understanding of what the possibilities are. I think that’s always the best is to just do your own research. Look at our website, we have a YouTube channel where we make educational videos. You want to get a better understanding of what FMT actually is, or what the gut microbiome is, but then book a call and talk with someone on our team to get an understanding if it is a good fit for you.
Lindsey:
Is there a cost for that initial call?
Shaina Cahill, PhD:
There’s no cost and you’re not tied into anything. We’re just as likely to say it’s not a good fit for you, because we want to make sure that anyone that’s coming to treatment with us is getting treatment that we think will work or will be a good fit. It may be that maybe it’s not a good fit for you now, or maybe we don’t think that it will be be helpful for the symptoms that you have, just as much as we want to answer your questions for you to be informed about making that decision. So we have that as an open ended so you can you don’t feel locked in, you don’t feel tied up with anything and then you can get an understanding of how it fits for you.
Lindsey:
Okay, awesome. Well, thank you so much for sharing about all this. I’m sure that there’s a lot of people who are curious about it and considering it.
If you’re struggling with dysbiosis, diarrhea, constipation, leaky gut, candida, IBS, IBD, or other gut health or all over body problems, you’re welcome to set up a free, 30-minute breakthrough session with me (Lindsey:). We’ll talk about what you’ve been going through and I’ll tell you about my 3- and 5- appointment health coaching programs in which I recommend lab tests, educate you on what the results mean and the protocols used by doctors to fix the problems revealed. Or if you’re ready to jump in right away or can just afford one appointment at a time, you can set up an 1-hour consultation with me.
