Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
United States20 participantsStarted 2022-08-08
Plain-language summary
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.
Who can participate
Age range10 Years – 60 Years
SexALL
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Inclusion criteria
✓. Aged \>=10 to \<=60 years.
✓. Able to provide informed consent (for ages \>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 years).
✓. Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence of colitis on colonoscopy).
✓. Fecal calprotectin level \>=200 microgram/g.
✓. HBI score \>=5 (to be evaluated on Day 1).
✓. No planned change in systemic antibiotic regimen for CGD for 1 month preceding FMT.
✓. No planned escalation in CGD-IBD treatment for 1 month preceding FMT.
✓. If taking monoclonal antibodies for CGD-IBD, the dose must be stable for 12 weeks with no planned escalation.
Exclusion criteria
✕. Evidence of acute GI infection, including active GI abscesses.
✕
What they're measuring
1
Difference in fecal calprotectin pre FMT and within 1 month post FMT.
Timeframe: Within 1 month
Trial details
NCT IDNCT05333471
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)