Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

Conditions

• Chronic Granulomatous Disease-associated Colitis

Eligibility Criteria

Sex

ALL

Age

10 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 8, 2022

Status verified

Feb 2026

Primary completion

Mar 1, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Interventional
  As this is a single arm study, this arm includes all participants. Participants will receive fecal microbiota transplantation (FMT) delivered by colonoscopy as a treatment for chronic granulomatous disease (CGD)-associated colitis (AC).

Primary Outcome Measure

Difference in fecal calprotectin pre FMT and within 1 month post FMT. [ Time Frame: Within 1 month ]

Central Contacts

• Suchitra K Hourigan, M.D.
  (240) 627-3995
  [email protected]

Locations (1)

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