Could poop pills heal gut damage in rare immune disease?
NCT ID NCT05333471
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether transplanting healthy donor stool into the gut can reduce colon inflammation in people with chronic granulomatous disease (CGD) who have colitis not helped by standard treatments. Twenty participants aged 10-60 will receive the transplant during a colonoscopy and be followed for 6 months. The goal is to see if this approach safely lowers inflammation and improves gut health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States