Mucosal Versus Fecal Microbiota in FMT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Clostridium Difficile

Keywords

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Clostridium difficile Intestinal Microbiota Transplantation Diarrhea Fecal Microbiota Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Colleen S Kraft MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen S. Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 24433460 (View on PubMed)

Other Identifiers

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IRB00069524

Identifier Type: -

Identifier Source: org_study_id