Mucosal Versus Fecal Microbiota in FMT

Clostridium Difficile Clinical Trial

Official title:

Characterization of the Microbial Genomics of Fecal Bacteriotherapy (FBT): Intestinal Microbiota Transplantation (IMT) for Recurring Clostridium Difficile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133651
• Other study ID #: IRB00069524
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: December 8, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clostridium Difficile

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No