Actively Recruiting
Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 10 to 60 years
- Able to provide informed consent or have a parent/guardian provide consent if under 18
- Confirmed diagnosis of chronic granulomatous disease (CGD) and CGD-associated colitis or CGD-IBD with colitis seen on colonoscopy
- Fecal calprotectin level of 200 microgram/g or higher
- Harvey-Bradshaw Index (HBI) score of 5 or higher
- No planned changes in systemic antibiotic treatment for CGD for 1 month before FMT
- No planned increase in CGD-IBD treatment for 1 month before FMT
- Stable dose of monoclonal antibodies for CGD-IBD for at least 12 weeks with no planned increase
- Agreement to use at least one highly effective method of contraception if able to become pregnant, from screening until study end
You will not qualify if you...
- Active gastrointestinal infection or abscesses
- Presence of Clostridium difficile toxin gene in stool
- History of intestinal obstruction related to CGD-IBD
- History of fistulizing CGD-IBD or intra-abdominal abscesses
- History of CGD-IBD related non-transversable intestinal strictures
- History of adverse events from previous FMT
- Significant liver disease including nodular regenerative hyperplasia, portal hypertension, or cirrhosis
- Pregnant or breastfeeding
- Severe food allergy
- Contraindication to colonoscopy under anesthesia
- Any condition that the investigator believes prevents safe participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Suchitra K Hourigan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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