CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1 enrolled
Drug / intervention
Low Dose FMT Capsule DE +2 moredrug
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/NCT03621657
NCT03621657Phase 2Completed
CompareCT.gov

A Phase II Randomized, Double-blind Placebo-controlled Trial to Determine if Fecal Microbiota Transplantation is Efficacious for Hospitalized Patients With C. Difficile Infection History During Antibiotic Treatment

University of Wisconsin, Madison·interventional·Posted Aug 8, 2018·Updated Mar 15, 2021

In Brief

A Phase 2 clinical trial evaluating Low Dose FMT Capsule DE, Single Dose FMT Capsule DE, and 1 other intervention for Clostridium Difficile Infection and 2 related conditions. Completed, enrolled 1 participant across 1 site.

Detailed Summary

The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo. The second objective is to assess the safety and feasibility of daily oral Fecal Microbiome Transplant (FMT) as a treatment option.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection, C.Difficile Diarrhea, CDI
CountriesUnited States
CollaboratorsAgency for Healthcare Research and Quality (AHRQ)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 8, 2018
Enrollment StartMar 21, 2019
Primary CompletionFeb 27, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.9 years ago

Interventions

Low Dose FMT Capsule DEdrug

5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.

Single Dose FMT Capsule DEdrug

30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.

Placebo oral capsuledrug

Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.