Recruiting
Phase 1

Stool Transplant

Sponsor:

Providence Holy Cross Medical Center

Code:

NCT02112279

Conditions

C-difficile

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Donor microbiota applied via colonoscopy.

Study Details

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

Study ID

NCT02112279

Start date

Apr, 2014

Status verified date

Jan, 2015

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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Exclusion Criteria:

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Microbiota Transplant

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

Interventions

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.

Primary outcome measure

  • Negative c-difficile test [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Robert B Moghimi, MD

818-363-7120rbm10105@yahoo.com

Sherri Mendelson, PhD, RN

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

Locations

Providence Holy Cross Medical Center

Recruiting

Mission Hills, California, United States, 91345

Contacts

Sherri G Mendelson, RN, PhD

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

Kelly Pagel, RN, BSN

818-365-8051Kelly.pagel@providence.org

Principal Investigator:

Robert Moghimi, MD

More Information

Sponsor

Providence Holy Cross Medical Center

Last update posted

Jan 8, 2015

Last verified

Jan, 2015

Keywords

  • Microbiota
  • c-difficile
  • colonoscopy
  • stool transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Providence Holy Cross Medical Center on 2015-01-08.