Fecal Microbiota Transplant for Auto-Brewery Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Antifungals, Warfarin, Immunosuppressants
Disqualifiers: Pregnancy, Severe immunodeficiency, Ulcerative colitis, Crohn's disease, Type I diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to study fecal microbiota transplantation(FMT) by oral capsule in people already diagnosed with auto-brewery syndrome (ABS, also known as gut fermentation syndrome). The main question it aims to answer: Is FMT safe and feasible in this syndrome? Participants will 1. have a "gut cleanout" with oral antibiotics and a colon cleanse, similar to that administered before colonoscopy 2. receive five oral doses of fecal transplant capsules over a week 3. be followed for six months for safety and research samples
Will I have to stop taking my current medications?
Participants must stop taking antifungals and any other complementary therapies for auto-brewery syndrome if they are currently using them. The protocol does not specify other medications, but certain medications like warfarin and suppressive antibacterial agents may affect eligibility.
What data supports the effectiveness of the treatment Fecal Microbiota Transplantation for Auto-Brewery Syndrome?
Fecal Microbiota Transplantation (FMT) is well-documented to be effective for treating recurrent Clostridium difficile infections, and there is some evidence suggesting it can help with ulcerative colitis. While these conditions are different from Auto-Brewery Syndrome, the success in altering gut bacteria in these cases may suggest potential benefits for other gut-related issues.12345
Is fecal microbiota transplantation (FMT) generally safe for humans?
FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. Long-term side effects are not well-established, but no significant harm has been found to date. However, serious adverse events have been associated with FMT products from stool banks that do not screen for multi-drug resistant organisms.678910
How does the treatment Fecal Microbiota Transplantation (FMT) differ from other treatments for Auto-Brewery Syndrome?
FMT is unique because it involves transferring stool from a healthy donor to a patient to restore a balanced gut microbiome, which is different from traditional treatments that might focus on medication or dietary changes. This approach is novel for Auto-Brewery Syndrome, as there are no standard treatments for this condition, and FMT is being explored for its potential to address underlying gut microbiota imbalances.111121314
Research Team
EH
Elizabeth Hohmann, MD
Principal Investigator
MGH
Eligibility Criteria
This trial is for adults aged 18-70 with Auto-Brewery Syndrome (ABS) who've had symptoms for at least a year, including alcohol production in the gut. They must have experienced multiple ABS flares and be able to travel to Boston. Excluded are those unable to swallow large capsules, pregnant women, people with severe illnesses or immune deficiencies, certain medication users, and individuals not fully vaccinated against COVID.Inclusion Criteria
Active ABS including at least 3 flares by either serum or breath alcohol levels in the past year (blood or breath samples)
My microbiome can produce alcohol outside my body.
I can travel to Boston for assessments and understand there's some reimbursement.
See 4 more
Exclusion Criteria
Severe food allergy or intolerance (donors are omnivores and do not maintain dietary restrictions)
Allergy to erythromycin, neomycin, or rifaximin
I often feel nauseous or vomit, or I frequently inhale food into my lungs.
See 14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Gut Cleanout
Participants undergo a gut cleanout with oral antibiotics and a colon cleanse
1 week
1 visit (in-person)
Treatment
Participants receive five oral doses of fecal transplant capsules over a week
1 week
Daily monitoring for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Intermittent visits at 2 weeks, 2 months, and 6 months
Treatment Details
Interventions
- Fecal Microbiota Transplantation (Microbiota Therapy)
Trial OverviewThe study tests fecal microbiota transplantation (FMT) via oral capsules after a 'gut cleanout' process. Participants will take five doses over one week and then be monitored for six months. The research aims to determine if FMT is safe and can help manage ABS by altering gut bacteria.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Active FMTExperimental Treatment1 Intervention
Active FMT (5 doses) over 7 days. Each dose contains 15 capsules.
Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
🇪🇺 Approved in European Union as Fecal Microbiota Transplantation for:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
- Other gastrointestinal disorders
🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Trials
3066
Patients Recruited
13,430,000+
National Institutes of Health (NIH)
Collaborator
Trials
2896
Patients Recruited
8,053,000+
University of California, San Diego
Collaborator
Trials
1215
Patients Recruited
1,593,000+
References
[Faecal microbiota transplantation for the treatment of bowel disease]. [2019]Faecal microbiota transplantation (FMT) is the transferral of faeces from a healthy donor to a patient with a disease linked to disturbances in the gut microbiota. The treatment has been implemented at several hospitals in Denmark, and banks with frozen donor stool material have been established. The effect of FMT for recurrent Clostridium difficile infection is well-documented. FMT cannot be recommended for routine clinical use for inflammatory bowel disease and irritable bowel syndrome because of lack of data from clinical trials.
[Patient perception and approval of fecal microbiota transplantation (FMT) as an alternative treatment option for ulcerative colitis]. [2022]Fecal microbiota transplantation (FMT) represents a treatment option for recurring Clostridium difficile-associated colitis. However, there is also evidence that FMT can be effective in treating ulcerative colitis. This study examined the approval and willingness of affected patients who underwent FMT.
Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. [2022]We aim to present a data detailing our success with fecal microbiota transplantation (FMT) and to provide a simple treatment protocol.
Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. [2023]Faecal microbiota transplantation (FMT) is recommended treatment for recurrent Clostridioides difficile infection and is studied as a potential modifier of other gastrointestinal and systemic disorders. Autologous FMT limits the potential risks of donor transplant material and enables prophylactic treatment. Capsulized FMT is convenient and accessible, but safety data are lacking.
Weight gain after fecal microbiota transplantation. [2022]Fecal microbiota transplantation (FMT) is a promising treatment for recurrent Clostridium difficile infection. We report a case of a woman successfully treated with FMT who developed new-onset obesity after receiving stool from a healthy but overweight donor. This case may stimulate further studies on the mechanisms of the nutritional-neural-microbiota axis and reports of outcomes in patients who have used nonideal donors for FMT.
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Clostridium difficile infection (CDI) treatment guideline from American Gastroenterology Association (AGA) recommends that FMT can be used as the treatment protocols of relapse CDI. Numerous case reports, retrospective case series, and randomized controlled trials have shown the benefit of FMT in patients with functional bowel disorders, including inflammatory bowel disease, irritable bowel syndrome and constipation, etc. Evidence regarding the safety of FMT is relatively limited because the very rapid adoption of FMT as a therapeutic modality for CDI occurred before the performance of large, long prospective trials that are typically conducted to assess the safety of new interventions. Potential adverse events can be categorized as short-term and long-term, and short-term events can further be divided into those related to the method of FMT delivery (colonoscopy, sedation) and those related to the FMT itself. Due to the recent emergence of FMT, little data exist regarding long-term events and many safety concerns are speculative. Capsulized FMT therapy solves the clinical problems associated with the use of fresh FMT suspensions for long-term maintenance i.e. repeat transplantation and invasive procedures, which is of great significance to optimize the traditional FMT clinical strategy. Future work will focus on establishing best practices and more robust safety data than exist currently, as well as refining FMT beyond current "whole-stool" transplants to increase safety and tolerability. Encapsulated formulations, full-spectrum stool-based products, and defined microbial consortia are all in the immediate future. Although challenges exist, regulatory agencies have been willing to work with stakeholders and will continue to evolve and adapt policy as therapeutics based on human gut microbiota research emerge.
Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Fecal microbiota transplantation (FMT) has shown excellent efficacy in treating Clostridioides difficile infection, as well as promise in several other diseases. The heightened interest is accompanied by concerns over adverse events (AE) and safety. To further understand that in FMT, we performed a systematic review of the literature and a meta-analysis of high-quality, prospective randomized controlled trials FMT.
Fecal Microbiota Transplantation: Is It Safe? [2021]Fecal microbiota transplantation (FMT) is an accepted procedure for the management of recurrent Clostridioides difficile infections. FMT is generally considered safe and well-tolerated - even in high-risk patients. Most short-term risks are mild and known to be associated with delivery methods. Long-term side effects have not been established, and no signs of harm have been found to date. However, causality for several microbiome-associated diseases has to be established. Even though FMT is generally considered safe with strict donor screening, serious adverse events have been recently associated with the FMT product from the stool bank, where screening for multi-drug resistant organisms is not included in protocols. Here, we discuss the adverse events associated with FMT and safety issues.
Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. [2022]The long-term efficacy and possible adverse events of fecal microbiota transplantation (FMT) for irritable bowel syndrome (IBS) are unknown. This study performed a 3-year follow-up of the patients in our previous clinical trial to clarify these aspects.
Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]To study the clinical efficacy and safety of Fecal microbiota transplantation (FMT). We systematically reviewed FMT used as clinical therapy.
Autologous fecal microbiota transplantation for the treatment of inflammatory bowel disease. [2021]The term autologous fecal microbiota transplantation (a-FMT) refers herein to the use of one's feces during a healthy state for later use to restore gut microbial communities after perturbations. Generally, heterologous fecal microbiota transplantation (h-FMT), where feces from a ``healthy" donor is transplanted into a person with illness, has been used to treat infectious diseases such as recurrent Clostridioides difficile infection (CDI), with cure rates of up to 90%. In humans, due to limited response to medicines, h-FMT has become a hallmark intervention to treat CDI. Extrapolating the benefits from CDI, h-FMT has been attempted in various diseases, including inflammatory bowel disease (IBD), but clinical response has been variable and less effective (ranging between 24% and 50%). Differences in h-FMT clinical response could be because CDI is caused by a Clostridial infection, whereas IBD is a complex, microbiome-driven immunological inflammatory disorder that presents predominantly within the gut wall of genetically-susceptible hosts. FMT response variability could also be due to differences in microbiome composition between donors, recipients, and within individuals, which vary with diet, and environments, across regions. While donor selection has emerged as a key factor in FMT success, the use of heterologous donor stool still places the recipient at risk of exposure to infectious/pathogenic microorganisms. As an implementable solution, herein we review the available literature on a-FMT, and list some considerations on the benefits of a-FMT for IBD.
[Fecal microbiota transplantation : current status and prospects]. [2019]Fecal microbiota transplantation (FMT) is approved as a safe and effective treatment of recurrent Clostridium difficile infections. The technique is now being studied for other indications, usually involving chronic inflammation, metabolic disorders, or autoimmunity, for which the gut microbiota appears to play a key role. We detail thereafter, according to their degree of evidence, the potential future indications, in which FMT has already been tried on Humans. Except for ulcerative colitis and metabolic syndrome, the methodology of the published trials is often insufficiently described and inhomogeneous. Further randomized placebo-controlled trials and standardization of practice will be needed to confirm these preliminary but encouraging results.
Fecal microbiota transplantation in gastrointestinal and extraintestinal disorders. [2021]Fecal microbiota transplantation (FMT) is the infusion of feces from a healthy donor into the gut of a recipient to treat a dysbiosis-related disease. FMT has been proven to be a safe and effective treatment for Clostridioides difficile infection, but increasing evidence supports the role of FMT in other gastrointestinal and extraintestinal diseases. The aim of this review is to paint the landscape of current evidence of FMT in different fields of application (including irritable bowel syndrome, inflammatory bowel disease, liver disorders, decolonization of multidrug-resistant bacteria, metabolic disorders and neurological disorders), as well as to discuss the current regulatory scenario of FMT, and hypothesize future directions of FMT.
Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. [2021]Label="Objectives">Fecal microbiota transplantation (FMT) is a recommended therapy for recurrent Clostridioides difficile infection and is being investigated as a potential therapy for dozens of microbiota-mediated indications. Stool banks centralize FMT donor screening and FMT material preparation with the goal of expanding access to FMT material while simultaneously improving its safety, quality, and convenience. Although there are published consensuses on donor screening guidelines, there are few reports about the implementation of those guidelines in functioning stool banks.