Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

Recruiting now · Phase 1/Phase 2

Conditions studied: Chronic Granulomatous Disease-associated Colitis

In brief

Background: Chronic granulomatous disease (CGD) weakens the body's defense against germs. CGD can also damage the colon. It can cause inflammation (colitis) that disrupts the good bacteria. Placing good bacteria from donor stool into the intestine of a person with CGD (called fecal microbiota transplantation, or FMT) may help. Objective: To see if FMT can reduce inflammation in the colon. Eligibility: People aged 10-60 who have CGD and colitis, and the treatments they have tried are not helping or have side effects. Design: Participants will have a telehealth screening visit. They will have a medical record review and medical history. They will collect stool samples at home and mail them to NIH. Participants will stay at the NIH hospital for 3-5 days. Each day, they will have the following: Physical exam Medical history and medicine review Surveys about CGD and how it affects their life Blood, stool, and urine tests Participants will have a colonoscopy. They will be sedated. A long, flexible tube will be inserted into their rectum. The tube will deliver the FMT material to their colon. Small samples of intestinal tissue will be collected. Participants may have an optional MRI of the digestive tract. Participants will have 9 follow-up telehealth visits over 6 months. They will be asked about their symptoms and side effects. They will fill out short surveys. They will collect stool and urine samples at home. Up to 2 visits can be done in person. At these visits, they may have the option to have an MRI and another colonoscopy to get more tissue samples. Participation will last for 6-7 months.

Key facts

Study ID

NCT05333471

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Starts

2022-08-08

Expected to finish

2027-03-01

Last updated by the study team

2026-03-31

Who can join

Age: 10 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Evidence of acute GI infection, including active GI abscesses.
• Presence of C difficile toxin gene in stool, as identified by PCR, in screening period.
• History of intestinal obstruction definitively related to CGD-IBD.
• History of fistulizing CGD-IBD or CGD-IBD intra-abdominal abscesses.
• History of CGD-IBD related non-transversable intestinal strictures.
• History of AEs attributable to previous FMT.
• History of significant liver disease (eg, biopsy-proven nodular regenerative hyperplasia), including portal hypertension or cirrhosis.
• Pregnant or breastfeeding.
• History of severe food allergy.
• Any contraindication to having colonoscopy under anesthesia.
• Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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