NCT05333471 Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
| NCT ID | NCT05333471 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Chronic Granulomatous Disease-associated Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-08-08 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-08-08 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Aged \>=10 to \<=60 years. 2. 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). 3. Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence of colitis on colonoscopy). 4. Fecal calprotectin level \>=200 microgram/g. 5. HBI score \>=5 (to be evaluated on Day 1). 6. No planned change in systemic antibiotic regimen for CGD for 1 month preceding FMT. 7. No planned escalation in CGD-IBD treatment for 1 month preceding FMT. 8. If taking monoclonal antibodies for CGD-IBD, the dose must be stable for 12 weeks with no planned escalation. 9. 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: 1. Evidence of acute GI infection, including active GI abscesses. 2. Presence of C difficile toxin gene in stool, as identified by PCR, in screening period. 3. History of intestinal obstruction definitively related to CGD-IBD. 4. History of fistulizing CGD-IBD or CGD-IBD intra-abdominal abscesses. 5. History of CGD-IBD related non-transversable intestinal strictures. 6. History of AEs attributable to previous FMT. 7. History of significant liver disease (eg, biopsy-proven nodular regenerative hyperplasia), including portal hypertension or cirrhosis. 8. Pregnant or breastfeeding. 9. History of severe food allergy. 10. Any contraindication to having colonoscopy under anesthesia. 11. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Contact & Investigator
Suchitra K Hourigan, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT05333471 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 60 Years, studying Chronic Granulomatous Disease-associated Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05333471 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05333471 currently recruiting?
Yes, NCT05333471 is actively recruiting participants. Contact the research team at suchitra.hourigan@nih.gov for enrollment information.
Where is the NCT05333471 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05333471 clinical trial?
NCT05333471 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Suchitra K Hourigan, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 20 participants.