Fecal Microbiota Transplant + Dietary Fiber for Graft-versus-Host Disease

Overseen By David Fredricks

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Bowel perforation, Inflammatory bowel disease, Celiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days for FMT administration, ongoing for fiber supplementation

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fecal microbiota transplants (using healthy donor stool to alter gut bacteria) combined with dietary fiber can treat gut graft-versus-host disease, a condition where transplanted cells attack the gut. Participants will receive the transplant either through capsules or colonoscopy, with some also receiving additional fiber. The study seeks individuals who have undergone a stem cell transplant in the past year and are experiencing mild to severe gut-related issues from graft-versus-host disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fecal microbiota transplantation (FMT) effectively and safely treats gut graft-versus-host disease. In past studies, patients tolerated FMT well and experienced positive results. While some reports suggest FMT can help manage symptoms, more research is needed to understand its long-term safety.

The addition of dietary fiber to FMT remains under study, and limited safety information is available. Researchers are testing whether combining FMT with fiber can enhance treatment effects. As this study is in its early stages, it primarily focuses on identifying potential risks and assessing patient responses to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for graft-versus-host disease (GVHD) because they explore the potential of fecal microbiota transplantation (FMT) combined with dietary fiber to modulate the gut microbiome, which is quite different from traditional immunosuppressive therapies. Unlike standard treatments that primarily focus on dampening the immune response, FMT aims to restore a healthy gut microbiome, potentially reducing inflammation and improving gut health. The addition of dietary fiber is thought to further support the growth of beneficial bacteria, offering a holistic approach to managing GVHD. This combination of FMT and fiber could offer a novel way to alleviate symptoms and improve patient outcomes by addressing the underlying microbiological environment in the gut.

What evidence suggests that this trial's treatments could be effective for gut graft versus host disease?

Research shows that fecal microbiota transplantation (FMT) can help manage gut graft-versus-host disease (GVHD). Studies have found that FMT improved the condition in patients unresponsive to other treatments, with success rates between 30% and 50%. This treatment introduces healthy bacteria from a donor into the patient's gut, restoring balance and reducing harmful inflammation. In this trial, participants will receive either upper or lower FMT. Additionally, some participants will receive dietary fiber supplementation alongside FMT, which may further support gut health by feeding good bacteria, although limited data exists on this combination. Overall, FMT is considered a promising and safe treatment option for gut GVHD. ^{1 2 3 6 7}

Who Is on the Research Team?

David Fredricks

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 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.

My white blood cell count has been stable for three days after a transplant.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota Transplantation
• Nutritional Supplementation

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm IV (Lower FMT, fiber supplementation) Experimental Treatment 5 Interventions

Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

Group II: Arm III (upper FMT, fiber supplementation) Experimental Treatment 4 Interventions

Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

Group III: Arm II (Lower FMT) Experimental Treatment 4 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 Treatment 3 Interventions

Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube 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)

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) is an effective treatment for restoring healthy gut bacteria in patients with disrupted intestinal microbiota, particularly in conditions like Clostridium difficile infection.

The review emphasizes the importance of careful donor selection and proper processing and storage of fecal material to ensure the safety and efficacy of the transplantation procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fecal microbiota transplantation: donor selection criteria, storage and preparation of biomaterials (review of current recommendations)]. Iakupova, AA., Abdulkhakov, SR., Safin, AG., et al.[2022]

Fecal microbiota transplantation (FMT) is a therapeutic procedure that involves transferring fecal matter from a healthy donor to treat diseases, particularly recurrent Clostridium difficile infections.

Recent research highlights the importance of the human microbiome, showing that the complex mixture of microorganisms in our bodies plays a crucial role in overall health and disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. Aroniadis, OC., Brandt, LJ.[2022]

Oral fecal microbiota transplantation (FMT) capsules were successfully used to treat a 31-year-old male with corticosteroid-refractory intestinal graft-versus-host disease (GvHD), leading to symptom relief and improved gut microbiota diversity after two treatment cycles.

Despite initial success, the patient's symptoms recurred after 11 days, highlighting the need for further research to optimize treatment protocols and assess the long-term efficacy and safety of oral FMT capsules in GvHD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of intestinal graft-versus-host disease with unrelated donor fecal microbiota transplantation capsules: A case report. Mao, D., Jiang, Q., Sun, Y., et al.[2022]

Fecal microbiota transplantation (FMT) in 27 patients with gastrointestinal graft-versus-host disease (GVHD) showed significant clinical improvement, with a faster partial response compared to placebo (median 4 days vs 48 days).

FMT led to increased bacterial diversity and specific beneficial bacteria populations, such as Bifidobacterium and Bacteroides fragilis, without a higher incidence of severe adverse events, indicating it is a safe and effective treatment option for refractory GI GVHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fecal microbiota transplantation for graft-versus-host disease in children and adults: methods, clinical effects, safety]. Goloshchapov, OV., Chukhlovin, AB., Bakin, EA., et al.[2020]

Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool banks in Denmark.

However, FMT is not recommended for routine use in treating inflammatory bowel disease or irritable bowel syndrome due to insufficient clinical trial data supporting its efficacy for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. Rode, AA., Chehri, M., Petersen, AM., et al.[2019]

Fecal microbiota transplantation (FMT) shows promise as a treatment for acute graft-versus-host disease (GVHD) in patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT), potentially improving outcomes related to HSCT complications.

While FMT can be beneficial, it must be approached with caution due to the high risk of infections in immunosuppressed HSCT recipients, highlighting the need for careful monitoring during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation for Treatment of Acute Graft-versus-Host Disease. Shouval, R., Geva, M., Nagler, A., et al.[2021]

Fecal microbiota transplantation (FMT) is primarily effective for treating recurrent Clostridium difficile infections by restoring a healthy microbiome in the colon.

Currently, there is not enough evidence to support the use of FMT for other gastrointestinal or nongastrointestinal diseases, although research is ongoing in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation. Vindigni, SM., Surawicz, CM.[2020]

Fecal microbiota transplantation (FMT) is recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

Disruptions in gut microbiota can lead to serious complications like graft-versus-host disease and infections in patients undergoing hematopoietic cell transplantation, highlighting the importance of maintaining a healthy microbiome.

Fecal microbiota transplantation (FMT) shows promise as a therapeutic intervention to restore gut health and potentially prevent adverse outcomes, but more research is needed to establish standardized protocols and best practices for its use in transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in hematopoietic cell transplant and cellular therapy recipients: lessons learned and the path forward. Habibi, S., Rashidi, A.[2023]

Fecal microbiota transplantation (FMT) has a reported adverse event (AE) rate of 39.3%, primarily involving mild and self-limiting issues like abdominal pain and diarrhea, based on a meta-analysis of 9 high-quality studies involving 756 FMTs.

Serious adverse events (SAE) were relatively rare at 5.3%, with the most common being Clostridium difficile infection, indicating that while FMT is generally safe, monitoring and standardized reporting are essential for understanding its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. Michailidis, L., Currier, AC., Le, M., et al.[2022]

Fecal microbiota transplantation (FMT) has proven to be highly effective in treating recurrent Clostridium difficile infection (RCDI), especially when other treatments fail, as supported by randomized controlled trials.

While FMT shows promise for other conditions like inflammatory bowel disease, it should only be used in these cases when strong evidence of efficacy is available, and long-term safety data is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation: current clinical efficacy and future prospects. Bowman, KA., Broussard, EK., Surawicz, CM.[2022]

Citations

1. nature.com nature.com/articles/s41467-025-56375-y

Fecal microbiota transplantation to prevent acute graft ... Donor fecal microbiota transplantation ameliorates intestinal graft-versus-host disease in allogeneic hematopoietic cell transplant recipients.

2. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04336-z

Fecal microbiota transplantation for refractory chronic graft ... Donor fecal microbiota transplantation ameliorates intestinal graft-versus-host disease in allogeneic hematopoietic cell transplant recipients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218917/

Fecal Microbiota Transfer in Acute Graft-versus-Host ... Overall response rates between 30 and 50% have been reported, but randomized trials are still pending. Newer approaches try to evaluate the role ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36167905/

Safety and efficacy of fecal microbiota transplantation in the ... This article evaluates the efficacy and safety of FMT in the treatment of GVHD after HSCT using a systematic literature search to conduct a meta-analysis ...

5. journals.lww.com journals.lww.com/ajg/abstract/2019/10001/201_efficacy_of_fecal_microbiota_transplantation.201.aspx

201 Efficacy of Fecal Microbiota Transplantation for Acute... CONCLUSION: FMT is a promising modality for management of gut GVHD and appears to be safe as a salvage therapy based on the current limited data. Ongoing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06938165

Study Details | NCT06938165 | The Safety and Efficacy of ... This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease ( ...

7. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2149/529238/Fecal-Microbiota-Transplantation-to-Prevent-Acute

Fecal Microbiota Transplantation to Prevent Acute Graft ... Fecal microbiota transplantation to prevent acute graft-versus-host disease: first pre-planned interim analysis of a randomized trial.