Mucosal Versus Fecal Microbiota in FMT
Characterization of the Microbial Genomics of Fecal Bacteriotherapy (FBT): Intestinal Microbiota Transplantation (IMT) for Recurring Clostridium Difficile
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 9, 2015
December 1, 2015
1.3 years
May 5, 2014
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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.
You may qualify if:
- Inpatient or outpatient adults, age ≥18
- Have had at least 1 relapse of C. difficile
- Patients who have had previous FMT
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University Hospital
Atlanta, Georgia, 30324, United States
Related 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.
PMID: 24433460BACKGROUND
Biospecimen
Fecal matter from the consented donor, consented recipient at 3 time points will be stored in a -80 freezer.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colleen S. Kraft, MD
Emory University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 8, 2014
Study Start
April 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12