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Stool Transplants to Treat Refractory Clostridium Difficile Colitis

NCT02127398 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Clostridium Difficile Colitis

Interventions

BIOLOGICAL

fecal microbiota

fecal microbiota in capsule form

Sponsors & Collaborators

Principal Investigators

  • Gary M Cox, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127398 on ClinicalTrials.gov