Reduction of C-Difficile Infection Using Stool Transplant

NCT02112279 | Unknown Phase 1

• 1 other identifier: PHC059
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiota; c-difficile; colonoscopy; stool transplant

Outcome Measures

Primary Outcomes (1)

• Negative c-difficile test

  Enrolled patients will test negative for c-difficile following application of the study intervention

  30 days

Secondary Outcomes (1)

• Relief of symptoms

  30 days

Study Arms (1)

Microbiota Transplant

EXPERIMENTAL

Close relative or purchased donor microbiota transplant will be administered via colonoscopy; Donor microbiota applied via colonoscopy

Biological: Donor microbiota applied via colonoscopy.

Interventions

Donor microbiota applied via colonoscopy. BIOLOGICAL

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.

Microbiota Transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years of age or older
• Patient must have a positive C. difficile test within the 10 days prior to the procedure
• Continued symptoms of c-difficile infection
• Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure

You may not qualify if:

• Under 18 years of age
• Negative C. difficile test within the 10 days prior to the procedure
• No symptoms of c-difficile infection
• Less than two courses of appropriate antibiotic therapy for C. difficile infection

Sponsors & Collaborators

• Providence Holy Cross Medical Center: lead

Study Sites (1)

Providence Holy Cross Medical Center

Mission Hills, California, 91345, United States

RECRUITING

Study Officials

• Robert B Moghimi, MD

  PHCMC

  PRINCIPAL INVESTIGATOR

• Ellsworth Pryor, MD

  Providence Holy Cross Medical Center

  PRINCIPAL INVESTIGATOR

• Sherri G Mendelson, RN, PhD

  Providence Holy Cross Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert B Moghimi, MD

CONTACT

818-363-7120; rbm10105@yahoo.com

Sherri Mendelson, PhD, RN

CONTACT

818-496-4390; Sherri.mendelson@providence.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Nursing Research and Magnet Program

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (1)