Fecal Microbiota Transplant for Small Intestinal Bacterial Overgrowth
Recruiting in Palo Alto (17 mi)
Overseen byNikhil Pai, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: McMaster Children's Hospital
Must not be taking: Antibiotics, Probiotics, Antacids, Antimotility
Disqualifiers: Under 3 years old, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The objective of the study is to assess feasibility, and clinical efficacy of a novel Fecal Microbiota Transplantation protocol for the treatment of pediatric small intestinal bacterial overgrowth (SIBO).
Will I have to stop taking my current medications?
You will need to stop taking antibiotics at least 1 week before the trial starts. You cannot start any new treatments, including antibiotics, probiotics, or antacids, until Week 8 unless it's necessary for your health.
What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Small Intestinal Bacterial Overgrowth?
Research shows that Fecal Microbiota Transplant (FMT) is effective for treating Clostridium difficile infections, which are also related to gut bacteria imbalances. This suggests potential benefits for other conditions involving gut bacteria, like Small Intestinal Bacterial Overgrowth.
12345Is fecal microbiota transplantation (FMT) 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. However, long-term safety data is limited, and serious adverse events have been associated with inadequate screening for multi-drug resistant organisms in some cases.
56789How is Fecal Microbiota Transplant (FMT) different from other treatments for Small Intestinal Bacterial Overgrowth?
FMT is unique because it involves transferring healthy donor feces into a patient's gut to restore a balanced microbiome, unlike traditional treatments that may use antibiotics to kill bacteria. This approach aims to directly modify the gut environment, potentially offering a novel way to address the root cause of bacterial overgrowth.
210111213Eligibility Criteria
This trial is for children and teenagers aged 3-18 who have been diagnosed with Small Intestinal Bacterial Overgrowth (SIBO) confirmed by a lactose breath test. Participants must show symptoms of SIBO and agree to stop taking antibiotics at least one week before the Fecal Microbiota Transplant (FMT).Inclusion Criteria
I am between 3 and 18 years old.
I will stop taking antibiotics 1 week before my fecal microbiota transplantation.
I have been diagnosed with SIBO through a breath test and show symptoms.
Exclusion Criteria
I am older than 3 years.
I won't start new treatments like antibiotics until after Week 8, unless necessary for my health.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single Fecal Microbiota Transplant (FMT) infusion via enteral feeding tubes or elective upper endoscopy
1 week
1 visit (in-person)
Short-term Follow-up
Participants are monitored for clinical efficacy and safety, with outcomes measured at one and four weeks post-FMT
4 weeks
2 visits (in-person)
Long-term Follow-up
Participants are monitored for long-term clinical efficacy, including durability of remission and recurrence of symptoms, with outcomes measured at eight weeks post-FMT
4 weeks
1 visit (in-person)
Participant Groups
The study is testing the feasibility and effectiveness of a new treatment protocol using Fecal Microbiota Transplant (FMT) to manage pediatric SIBO.
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TranspantExperimental Treatment1 Intervention
Participants will receive a Fecal Microbiota transplant Infusion via participants' existing enteral feeding tubes or via elective upper endoscopy (with infusion into the duodenum). Most patients with SBS at MCH and HSC have an existing enteral feeding tube (gastrostomy or jejunostomy tube).
Fecal Microbiota Transplant is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:
- Recurrent and refractory Clostridioides difficile infection
🇪🇺 Approved in European Union as Faecal Microbiota Transplantation for:
- Recurrent and refractory Clostridioides difficile infection
🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:
- Recurrent and refractory Clostridioides difficile infection
🇦🇺 Approved in Australia as Faecal Microbiota Transplantation for:
- Recurrent and refractory Clostridioides difficile infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McMaster Children's HospitalHamilton, Canada
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Who Is Running the Clinical Trial?
McMaster Children's HospitalLead Sponsor
The Hospital for Sick ChildrenCollaborator
References
Systematic review with meta-analysis: review of donor features, procedures and outcomes in 168 clinical studies of faecal microbiota transplantation. [2020]Faecal microbiota transplantation (FMT) is effective for Clostridium difficile infections (CDI) refractory to standard treatment and is being studied in other diseases.
[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.
Faecal Microbiota Transplantation is a simple, effective and safe treatment in the management of C. difficile infection in daily clinical practice. [2023]Faecal microbiota transplantation (FMT) is a treatment supported by wide scientific evidence and proved to be very effective in the management of Clostridioides difficile infection (CDI). The objective of this study is to analyze its effectiveness and safety in a real clinical practice setting.
The role of faecal microbiota transplantation in the treatment of inflammatory bowel disease. [2021]Faecal microbiota transplantation (FMT) has emerged as a potent form of therapeutic microbial manipulation. There is much interest in exploring its potential in conditions such as inflammatory bowel disease (IBD) where disturbances in the gastrointestinal microbiota play a crucial role in disease pathogenesis.
Long-term safety and efficacy of fecal microbiota transplantation in 74 children: A single-center retrospective study. [2022]Fecal microbiota transplantation (FMT) is an effective treatment for intestinal and extra-intestinal disorders. Nonetheless, long-term safety and efficacy remain major challenges for FMT applications. To date, few long-term follow-up studies have been published on FMT in children.
[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.
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.
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.
Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]Fecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT.
Fecal microbiota transplantation as a new therapy: from Clostridioides difficile infection to inflammatory bowel disease, irritable bowel syndrome, and colon cancer. [2020]Fecal microbiota transplantation (FMT) represents the most effective means of therapeutically manipulating the gastrointestinal microbiome. Originally employed as a treatment of last-resort in patients with life-threatening Clostridioides difficile infection (CDI), FMT gained widespread acceptance during the CDI epidemic, where it achieved resolution rates approaching 100%. Following our newfound appreciation for the role of the gut microbiome in both health and disease and owing to FMT's unique mechanism/s of action, FMT is rapidly advancing as an effective treatment for a number of conditions in which the gastrointestinal microbiome is thought to play a role. We review the role of FMT from its beginnings in CDI to its expansion into inflammatory bowel disease, irritable bowel syndrome, and colon cancer.
Faecal microbiota transfer in patients with microscopic colitis - a pilot study in collagenous colitis. [2021]Faecal microbiota transfer (FMT) consists of the infusion of donor faecal material into the intestine of patients with the aim to restore a disturbed gut microbiota.