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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02133651
Other study ID # IRB00069524
Secondary ID
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


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
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