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NCT01868373

Defined Fecal Microbiota Transplantation for Clostridium Difficile Diarrhea

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
Baylor College of Medicine
~12 participants
Updated 2023-06-27 on ClinicalTrials.gov
What's tested:Microbiota Transplantation (FMT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binomial: success defined as resolution or no resolution of disease. Resolution is defined as either complete cessation of clinical symptoms or diagnostic confirmation of the absence of disease, during the period of follow-up after transplantation.
Measured over 8 weeks

Conditions

Active C. Difficile Colitis

Explore related trials

Clostridium difficile Infection

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • David Y Graham, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
  • Antone R Opekun, MS, PA-C · STUDY_CHAIR · Baylor College of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Binomial: success defined as resolution or no resolution of disease. Resolution is defined as either complete cessation of clinical symptoms or diagnostic confirmation of the absence of disease, during the period of follow-up after transplantation.8 weeks

    The outcome is binomial. Success defined as resolution or not. Resolution is defined as either complete cessation of symptoms or diagnostic confirmation of the absence of disease during the follow-up period. Resolution after 1 treatment is counted separately from resolution after retreatment due to failure. The scales used are failure or resolution with Type 1 Failure being defined as the continued occurrence of clinical illness during (1) the period of 8 weeks follow-up \& before retreatment or (2) Type 2 Failure as failure during the period of 8 weeks of follow-up subsequent to retreatment. Relapse is defined as resolution, with subsequent return of signs \& symptoms during the follow-up period confirmed by return of stool toxin and/or the typical endoscopic findings of C. difficile colitis.