Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

• Status: Recruiting
• Trial end date: 2023-11-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Anti-Infective Agents

Criteria

Inclusion Criteria:

1. One or more episodes recurrent CDI (defined as > 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis PLUS laboratory confirmation of C. difficile; or ileus, or toxic megacolon PLUS laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation)

2. Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement

3. Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later.

4. Age 18 years

5. Enrolled in a VHA facility

6. Able and willing to provide informed consent

Exclusion Criteria:

1. Unlikely to swallow capsules

2. Pregnancy, planning to be pregnant, or breastfeeding

3. Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (absolute neutrophil count of < 1,000 cells/ L) within the past 3 months

4. Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI

5. Ongoing antibiotic use other than those for the current episode of CDI

6. Prior FMT

7. Life expectancy of < 8 weeks

8. Anaphylactic food allergy

9. Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval

10. Presence of an ileostomy or colostomy

11. HIV with CD4 count < 200 cells/µL in prior 3 months

12. Decompensated cirrhosis

13. Bone marrow/peripheral blood stem cell transplant in the past year

14. Unlikely to follow study protocol