Status:
RECRUITING
Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chronic Granulomatous Disease-associated Colitis
Eligibility:
All Genders
10-60 years
Phase:
PHASE1
PHASE2
Brief 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 g...
Detailed Description
Study Description: This is a prospective, single-site, single-arm, open-label pilot trial to evaluate the use of fecal microbiota transplantation (FMT) delivered by colonoscopy as a treatment for chr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
- Participants who can become pregnant must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy, starting at screening until the end of study participation. Highly effective methods include a barrier (eg, condom, diaphragm, cervical cap), intrauterine device, or hormonal contraception.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
August 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05333471
Start Date
August 8 2022
End Date
March 1 2026
Last Update
December 17 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892