Mucosal Versus Fecal Microbiota in FMT

Completed

• Conditions: Clostridium Difficile

• Registration Number: NCT02133651
• Lead Sponsor: Emory University

Brief Summary

Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea. Treatment of this infection usually occurs using other antibiotics, but many individuals have persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal Microbiota Transplantation, (IMT) has been shown to be efficacious when administered after treatment for C. difficile. This study will involve taking biopsies from patients during their FMT/IMT via colonoscopy, and determine if there are differences in the mucosal flora as compared to the stool flora. The investigators hope to discover the critical parts of a healthy microbiota.

Detailed Description

A total of 20 subjects with at least one relapse of Clostridium difficile infection undergoing Intestinal Microbiota Transplantation via colonoscopy will be recruited in this study. The patients will produce a stool specimen at the time of colonoscopy and a biopsy will be obtained during the colonoscopy. At 2 weeks and 10 weeks, stool specimens and anoscopy will be collected to be tested for C. difficile polymerase chain reaction (PCR) and the fecal microbiota. Subjects will be referred from all locations of Emory Healthcare.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Inpatient or outpatient adults, age ≥18
• Have had at least 1 relapse of C. difficile
• Patients who have had previous FMT

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Exclusion Criteria

• Pregnant or breastfeeding
• Critically or acutely ill (Fever will be defined as a documented temperature >37.8°C)
• Ileus or toxic megacolon
• Unable to give consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who experience resolution of diarrhea associated with C. difficile infection without relapse 2 weeks and 10 weeks post Intestinal Microbiota Transplantation (IMT)	10 weeks post IMT

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States