RECRUITING

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

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Conditions

Clostridium Difficile Infection RecurrenceClostridium Difficile Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-01-16
Study Completion:2027-01-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03562741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.
  2. * Failed standard therapy with oral metronidazole and/or oral vancomycin
  3. * One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity
  1. * Age \<16 years old
  2. * patients with acute severe colonic dilation at risk for colonic perforation

Contacts and Locations

Study Contact

Anne Foley
CONTACT
Anne.Foley@umassmed.edu

Principal Investigator

Krunal Patel
PRINCIPAL_INVESTIGATOR
UMass Medical School

Study Locations (Sites)

UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: Krunal Patel

  • Krunal Patel, PRINCIPAL_INVESTIGATOR, UMass Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-01-16
Study Completion Date2027-01-16

Study Record Updates

Study Start Date2014-01-16
Study Completion Date2027-01-16

Terms related to this study

Additional Relevant MeSH Terms

  • Clostridium Difficile Infection Recurrence
  • Clostridium Difficile Infection