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NCT05333471 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
A Phase 1 study of Chronic Granulomatous Disease-associated Colitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05333471: Recruiting Phase 1 study of Chronic Granulomatous Disease-associated Colitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05333471 is a Phase 1 study of Chronic Granulomatous Disease-associated Colitis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05333471, a Phase 1 study of Chronic Granulomatous Disease-associated Colitis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To evaluate the change in intestinal inflammation pre-FMT vs post FMT
Conditions Studied
Interventions
- DRUG MTP 101-LF
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
What NCT05333471 shows while recruiting
NCT05333471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Chronic Granulomatous Disease-associated Colitis appearing as the primary indexed condition, and to 1 intervention - of which MTP 101-LF is the first listed.
NCT05333471 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05333471 about?
NCT05333471 is a clinical study titled "Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis". 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 trans...
What is the current status of trial NCT05333471?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-08-08. Estimated completion is 2027-03-01.
What conditions does trial NCT05333471 study?
This clinical trial studies the following conditions: Chronic Granulomatous Disease-associated Colitis.
What interventions are being tested in trial NCT05333471?
The interventions under investigation include: MTP 101-LF (DRUG).
Who is sponsoring clinical trial NCT05333471?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05333471 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05333471's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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