Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Part of paid clinical trials in Durham, North Carolina.

Sponsor: Duke University
Study ID: NCT02127398
Phase: PHASE2
Status: Recruiting

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Conditions

Clostridium Difficile Colitis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

fecal microbiota — BIOLOGICAL
fecal microbiota in capsule form

Study Details

It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor. The investigators wish to transplant stool from healthy donors to treat recurrent C. difficile colitis by incorporating the stool into capsules that are administered by the oral route.

Key Dates

Start date: Apr 30, 2016
Status verified: Aug 2025
Primary completion: May 31, 2026
Completion: May 31, 2026

Study Design

Enrollment: 77 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: fecal microbiota transplantation
fecal microbiota transplantation

Primary Outcome Measure

Recurrent colitis due to Clostridium difficile [ Time Frame: six months ]

Central Contacts

Gary M Cox, MD
919-668-3271
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Duke University Medical Center	Durham	North Carolina	27710	Gary M Cox, MD [email protected] 919-668-3271 Gary M Cox, MD (PRINCIPAL_INVESTIGATOR)

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Duke University Medical Center· Durham, NC