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Reduction of C-Difficile Infection Using Stool Transplant

NCT02112279 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-01-08

No results posted yet for this study

Summary

Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett \& Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile.

The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort.

Conditions

  • C-difficile

Interventions

BIOLOGICAL

Donor microbiota applied via colonoscopy.

B. Preparation of donor sample 1. Instillation via Colonoscopy 1\. Stool mixture is administered into the terminal ileum and cecum through the biopsy channel of a colonoscope while the patient is sedated. Administer 300-700 ml of slurry through biopsy channel of colonoscope with a piston syringe.

Sponsors & Collaborators

  • Providence Holy Cross Medical Center

    lead OTHER

Principal Investigators

  • Robert B Moghimi, MD · PHCMC

  • Ellsworth Pryor, MD · Providence Holy Cross Medical Center

  • Sherri G Mendelson, RN, PhD · Providence Holy Cross Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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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 NCT02112279 on ClinicalTrials.gov