Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
Krunal Patel
Study ID
NCT03562741
Status
Recruiting
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Conditions

  • Clostridium Difficile Infection
  • Clostridium Difficile Infection Recurrence

Eligibility Criteria

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

Interventions

  • Fecal Microbiota Transplantation — PROCEDURE
    Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation

Study Details

The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.

Key Dates

Start date
Jan 16, 2014
Status verified
Feb 2026
Primary completion
Jan 16, 2028
Completion
Jan 16, 2029

Study Design

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

Arms

  • Experimental: Fecal Microbiota Transplantation
    Subjects receive intervention of stool transplanted to the colon via colonoscopy.

Primary Outcome Measure

Clostridium Difficile (C. diff) resolution' [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Memorial Medical CenterWorcesterMassachusetts01655
Krunal Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Worcester, MA

By research site
UMass Memorial Medical Center· Worcester, MA

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