Mucosal Versus Fecal Microbiota in FMT

Emory University

Status: Completed

Conditions: Clostridium Difficile

Study type: Observational

Funder types: Other

Identifiers

NCT02133651

IRB00069524

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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