CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Fecal Microbiotabiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02318992
NCT02318992Phase 2Completed
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Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea

The University of Texas Health Science Center, Houston·interventional·Posted Dec 18, 2014·Updated May 23, 2024

In Brief

A Phase 2 clinical trial evaluating Fecal Microbiota for Recurrent C. Difficile Associated Diarrhea. Completed, enrolled 79 participants across 1 site.

Detailed Summary

The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be generated from well-screened healthy volunteer donors of ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors and recipients will be saved for later metagenomic studies to characterize the microbiome of the gut in patients before and after FMT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent C. Difficile Associated Diarrhea
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 18, 2014
Enrollment StartAug 1, 2013
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.5 years ago

Interventions

Fecal Microbiotabiological

Fecal Microbiota will be delivered via colonoscopy.