FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI within 90 days of an admission for relapse of CDI will be approached to participate in this open-label, randomized controlled trial. Patients will either be randomized to the intervention group (receive FMT via retention enema) or the control group (receive antimicrobials targeting CDI).

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

Details

• Lead Sponsor: NorthShore University HealthSystem
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents

Criteria

Inclusion Criteria:

• Diagnosis of active C. difficile infection, defined as > 3 diarrheal stools per day and a positive C. difficile PCR assay

• Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90 days after an index episode of CDI

Exclusion Criteria:

• Pregnancy

• Neutropenia (absolute neutrophil count <1000/microliters)

• Contraindication for retention enema

• Food allergy not controlled in the donor diet