RecruitingPhase 1Phase 2NCT05333471

Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

A Pilot Study of Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

20 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Granulomatous Disease-associated Colitis

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

Min Age: 10 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor — can help treat colitis (bowel inflammation) in people with Chronic Granulomatous Disease (CGD), a rare immune system disorder. You may be eligible if: - You are between 10 and 60 years old - You have confirmed diagnoses of CGD and CGD-associated colitis - Your fecal calprotectin level is at or above 200 micrograms/g (a marker of intestinal inflammation) - Your Harvey-Bradshaw Index score is 5 or higher at your first visit - Your antibiotic regimen and bowel disease treatment have been stable for at least 1 month You may NOT be eligible if: - You have an active gut infection or abscess - You have C. difficile toxin in your stool - You have a history of bowel obstruction, fistulizing disease, or non-traversable bowel strictures related to CGD - You have significant liver disease, portal hypertension, or cirrhosis - You are pregnant or breastfeeding - You have a history of serious food allergy or a contraindication to colonoscopy under anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMTP 101-LF

Each unit of MTP-101-LF contains approximately 35 mL of fecal transplant product. Participants will receive approximately 32 mL via colonoscopy.

Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05333471