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Fecal Microbiota Transplantation

Fecal Microbiota Transplantation for Colitis

Phase 1 & 2
Recruiting
Led By Suchitra K Hourigan, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged >=10 to <=60 years
Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence of colitis on colonoscopy)
Must not have
History of fistulizing CGD-IBD or CGD-IBD intra-abdominal abscesses
Evidence of acute GI infection, including active GI abscesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if placing healthy bacteria from donor stool into the intestines of people with CGD and colitis can reduce inflammation. The target group is patients aged 10-60 who haven't responded to other treatments. The goal is to restore a healthy balance of gut bacteria to reduce inflammation. This method has shown promise in treating inflammatory bowel diseases like ulcerative colitis by restoring a healthy gut balance.

Who is the study for?
This trial is for people aged 10-60 with Chronic Granulomatous Disease (CGD) and colitis who haven't responded well to other treatments. They must have a specific level of inflammation marker in their stool, no recent changes in antibiotics or escalation in CGD treatment, and if they can get pregnant, agree to use effective contraception.
What is being tested?
The trial tests whether transplanting good bacteria from donor stool into the intestines (Fecal Microbiota Transplantation - FMT) can reduce colon inflammation in CGD patients. Participants will undergo various tests including a colonoscopy to deliver the FMT material and follow-up telehealth visits over 6 months.
What are the potential side effects?
Potential side effects may include discomfort or risks associated with colonoscopy procedures such as bleeding or perforation, reactions to sedatives used during the procedure, abdominal pain, bloating, diarrhea or constipation following FMT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 60 years old.
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I have been diagnosed with CGD and CGD-AC or CGD-IBD, with colitis confirmed by colonoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had complications from inflammatory bowel disease, like fistulas or abscesses.
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I do not have an active infection in my digestive system.
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I have had a blockage in my intestines due to CGD-related IBD.
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I have a history of serious liver disease, such as cirrhosis.
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I cannot have a colonoscopy with anesthesia due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in fecal calprotectin pre FMT and within 1 month post FMT.
Secondary study objectives
Difference in PRO-2 pre-FMT and within 1 month post-FMT.
Differences in alpha diversity, beta diversity, and relative abundance of taxa pre-FMT within 1 month post-FMT and assessment of engraftment of donor microbiome and Assessment of engraftment of donor microbiome.
Treatment-Emergent Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
As this is a single arm study, this arm includes all participants. Participants will receive fecal microbiota transplantation (FMT) delivered by colonoscopy as a treatment for chronic granulomatous disease (CGD)-associated colitis (AC).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colitis include anti-inflammatory drugs (such as mesalamine), corticosteroids, immunosuppressants, and biologics. These treatments work by reducing inflammation, suppressing the immune response, and targeting specific pathways involved in the inflammatory process. Fecal Microbiota Transplantation (FMT) is a treatment that aims to restore healthy gut microbiota by introducing beneficial bacteria from a donor's stool into the patient's colon. This can help rebalance the gut microbiome, reduce inflammation, and improve symptoms. For colitis patients, restoring a healthy gut microbiota is crucial as it can enhance the gut's barrier function, modulate the immune response, and potentially lead to long-term remission.
Efficacy and safety of fecal microbiota transplant for recurrent Clostridium difficile infection in inflammatory bowel disease: a systematic review and meta-analysis.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,317 Previous Clinical Trials
5,547,851 Total Patients Enrolled
10 Trials studying Colitis
2,831 Patients Enrolled for Colitis
Suchitra K Hourigan, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
3 Previous Clinical Trials
640 Total Patients Enrolled
1 Trials studying Colitis

Media Library

OpenBiome FMT product FMP250 (Fecal Microbiota Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT05333471 — Phase 1 & 2
Colitis Research Study Groups: Interventional
Colitis Clinical Trial 2023: OpenBiome FMT product FMP250 Highlights & Side Effects. Trial Name: NCT05333471 — Phase 1 & 2
OpenBiome FMT product FMP250 (Fecal Microbiota Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333471 — Phase 1 & 2
~4 spots leftby Jul 2025