Fecal Microbiota Transplant + Dietary Fiber for Graft-versus-Host Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Fred Hutchinson Cancer Research Center
Disqualifiers: Bowel perforation, Inflammatory bowel disease, Celiac disease, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
What data supports the effectiveness of the treatment Fecal Microbiota Transplantation (FMT) combined with dietary fiber for graft-versus-host disease?
Research indicates that Fecal Microbiota Transplantation (FMT) has shown promise in treating intestinal graft-versus-host disease (GvHD) by restoring a healthy balance of gut bacteria. While FMT is well-documented for treating recurrent Clostridium difficile infections, its use in GvHD is still being explored, with some studies suggesting potential benefits but also highlighting the need for caution due to possible risks in immunosuppressed patients.
12345Is fecal microbiota transplantation (FMT) generally safe for humans?
Fecal microbiota transplantation (FMT) has shown promise in treating certain conditions, but safety data is still limited, especially for long-term effects. While it is generally considered safe, there are potential risks, particularly for people with weakened immune systems, as unexpected infections may occur.
24678How is the treatment Fecal Microbiota Transplantation (FMT) unique for graft-versus-host disease?
Fecal Microbiota Transplantation (FMT) is unique because it involves transferring stool from a healthy donor to a patient to restore the balance of gut bacteria, which can help manage graft-versus-host disease by improving the immune system's function. Unlike traditional treatments, FMT directly targets the gut microbiome, offering a novel approach to managing this condition.
2391011Eligibility Criteria
This trial is for adults over 18 who had a stem cell transplant in the last 100 days and are now experiencing mild to severe gut graft versus host disease. They must not have a history of serious bowel issues or allergies to specific medications, and women must not be pregnant or breastfeeding.Inclusion Criteria
I am 18 years old or older.
I had a stem cell transplant from a donor within the last 100 days.
I have mild to severe GI issues due to a recent transplant.
+1 more
Exclusion Criteria
I have had a blockage in my intestines before.
I have had a bowel perforation in the past.
History of previous serious adverse events associated with FMT
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients receive fecal microbiota transplant (FMT) and dietary fiber supplementation as per randomization arm
2 days for FMT administration, ongoing for fiber supplementation
Multiple visits for sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
365 days
Long-term monitoring
Participants are monitored for adverse events and quality of life
Up to 3 years
Participant Groups
The study tests if fecal microbiota transplants (donor stool into the patient's gut) combined with dietary fiber can treat gut graft versus host disease after stem cell transplantation. It includes colonoscopies and surveys to monitor effects.
4Treatment groups
Experimental Treatment
Group I: Arm IV (Lower FMT, fiber supplementation)Experimental Treatment5 Interventions
Patients undergo lower FMT via colonoscopy on day 0. Patients receive fiber supplementation PO while on study. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.
Group II: Arm III (upper FMT, fiber supplementation)Experimental Treatment4 Interventions
Patients receive upper FMT capsules PO over 2 days. Patients receive fiber supplementation PO while on study. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.
Group III: Arm II (Lower FMT)Experimental Treatment4 Interventions
Patients undergo lower FMT via colonoscopy on day 0. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.
Group IV: Arm I (upper FMT)Experimental Treatment3 Interventions
Patients receive upper FMT capsules PO over 2 days. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.
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:
Fred Hutch/University of Washington Cancer ConsortiumSeattle, WA
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Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
Fred Hutchinson Cancer CenterLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Fecal microbiota transplantation in hematopoietic cell transplant and cellular therapy recipients: lessons learned and the path forward. [2023]Disruptions to the gut microbiota have been associated with adverse outcomes including graft-versus-host disease, infections, and mortality after hematopoietic cell transplantation and cellular therapy. Evidence for causal links is accumulating, thus supporting therapeutic interventions targeting the microbiota with the goal of preventing and treating adverse outcomes. One such intervention is fecal microbiota transplantation (FMT) by which an entire community of gut microbiota is transferred to the patient with dysbiosis. As this approach in transplant and cellular therapy recipients is still in its infancy, no best approach has been defined and many open questions need to be addressed before FMT becomes a standard treatment. In this review, we highlight microbiota-outcome associations with the highest level of evidence, provide an overview of the main FMT trials, and suggest some paths forward.
Fecal Microbiota Transplantation for Treatment of Acute Graft-versus-Host Disease. [2021]The growing understanding of the bidirectional relationship between the gastrointestinal (GI) microbiome and the immune system has opened up new avenues for treatment of graft-versus-host disease (GVHD). Fecal microbiota transplantation (FMT) is the transfer of stool from a donor to a recipient who harbors a perturbed GI microbiome resulting in disease. We review the rationale for performing FMT for the treatment of acute GVHD, and summarize data on the safety and efficacy of the procedure among allogeneic hematopoietic stem cell transplantation (HSCT) recipients. Overall, FMT is a promising strategy in treating and preventing HSCT-related complications. However, caution should be exerted as HSCT recipients are highly immunosuppressed and unanticipated infectious adverse events may appear with the increasing application of FMT.
[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.
[Fecal microbiota transplantation for graft-versus-host disease in children and adults: methods, clinical effects, safety]. [2020]Was to evaluate clinical efficacy, adverse events and changes in the gut microbiome after fecal microbiota transplantation (FMT) in patients with gastrointestinal (GI) form of graft-versus-host disease (GVHD).
Treatment of intestinal graft-versus-host disease with unrelated donor fecal microbiota transplantation capsules: A case report. [2022]Fecal microbiota transplantation (FMT), administering fecal suspensions via a nasoduodenal tube, has achieved a promising effect in the treatment of intestinal graft-versus-host disease (GvHD) in some pilot studies. In this study, oral FMT capsules from unrelated donor were used for the first time in the treatment of intestinal GvHD. Patient concerns: A 31-year-old male who was diagnosed as "myelodysplastic syndromes with excess blasts II" (intermediate risk 2 of international prognostic scoring system) received human leukocyte antigen -matched sibling donor allogeneic hematopoietic stem cell transplantation. The patient developed diarrhea, vomiting, and bloody stool on 28 days after transplantation.
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.
[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.
Fecal microbiota transplantation: current clinical efficacy and future prospects. [2022]Fecal microbiota transplantation (FMT) has gained mainstream attention with its remarkable efficacy in treating recurrent Clostridium difficile infection (RCDI) when there are no other effective therapies. Methods of selecting donors and routes of administration vary among studies, but there are now randomized controlled trials showing efficacy of FMT in treating RCDI. Ongoing trials of FMT for other disease such as inflammatory bowel disease are underway; this therapy should not be used for these conditions unless there is strong evidence for efficacy. Long-term safety data are sorely needed, as well as clarification of regulatory concerns.
[Fecal microbiota transplantation: donor selection criteria, storage and preparation of biomaterials (review of current recommendations)]. [2022]Fecal microbiota transplantation is a treatment method based on the introduction of donated fecal material to the recipient in order to restore the damaged composition of the intestinal microbiota. This review summarizes existing data on indications for fecal microbiota transplantation, recommendations for donor selection, processing and storage of donor biomaterial.
Fecal Microbiota Transplantation. [2020]Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor into the colon of a patient whose disease is a result of an altered microbiome, with the goal of restoring the normal microbiota and thus curing the disease. The most effective and well-studied indication for FMT is recurrent Clostridium difficile infection. At this time, there is insufficient evidence to recommend FMT for other gastrointestinal diseases, but studies are under way. There is also insufficient evidence to recommend FMT for nongastrointestinal diseases at this time. The field is rapidly emerging.
Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. [2022]Fecal microbiota transplantation (FMT) refers to the infusion of a fecal suspension from a healthy person into the gastrointestinal (GI) tract of another person to cure a specific disease. FMT is by no means a new therapeutic modality, although it was only relatively recently that stool was shown to be a biologically active, complex mixture of living organisms with great therapeutic potential for recurrent Clostridium difficile infection and perhaps other GI and non-GI disorders. The published revelations about the human microbiome are bringing the strength of science to clinical observation and enhancing the understanding of not only disease but also how much of a person's daily function and health depends on the microorganisms living in intimate relationship with each cell in the body.