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Gut Microbiota Changes After Fecal Microbiota Transplantation

NCT02557685 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-09-23

No results posted yet for this study

Summary

This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses.

This will be an open label clinical trial of FMT to prevent further recurrence in patients who have suffered at least a third episode of Clostridium difficile infection (CDI) and who have previously been treated with oral vancomycin.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

Fecal Microbiota Translantation involves administering fecal material from a healthy donor to a sick patient, with relapsing C-difficile infection, to restore missing components of normal intestinal flora. Subjects will receive Fecal Microbiota Translantation via sigmoidoscopy.

Sponsors & Collaborators

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Colleen Kelly, MD · The Miriam Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-31
Completion
2017-03-31

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 NCT02557685 on ClinicalTrials.gov