Clinical trial NCT02133651: Mucosal Versus Fecal Microbiota in FMT
Official title: Characterization of the Microbial Genomics of Fecal Bacteriotherapy (FBT): Intestinal Microbiota Transplantation (IMT) for Recurring Clostridium Difficile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile
Keywords: Clostridium difficile
Intestinal Microbiota Transplantation
Diarrhea
Fecal Microbiota Transplant
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Clostridium difficile infection at least twice and will be undergoing intestinal microbiota transplantation (IMT) via a colonoscopy for treatment from Emory University Hospital and Emory University Midtown.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 10 weeks post IMT
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Colleen S. Kraft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman-Moraco RJ, Mehta AK, Lyon GM, Kraft CS. Fecal microbiota transplantation for refractory Clostridium difficile colitis in solid organ transplant recipients. Am J Transplant. 2014 Feb;14(2):477-80. doi: 10.1111/ajt.12577. Epub 2014 Jan 16.