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NCT03617445 · ClinicalTrials.gov registry record · Phase 2

Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

A Phase 2 study, sponsored by University of Wisconsin, Madison.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT03617445: Clinical Trial Phase 2 study, sponsored by University of Wisconsin, Madison.

NCT03617445 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03617445, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

Primary Outcome

Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period)

Interventions

  • DRUG Oral Vancomycin
  • DRUG FMT oral capsule
  • DRUG FMT oral placebo
  • DRUG Oral Vancomycin placebo

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2022-08-03
Est. Completion 2023-06-01
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

Why NCT03617445 stopped before completion

NCT03617445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 4 interventions - of which Oral Vancomycin is the first listed.

NCT03617445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03617445 about?

NCT03617445 is a clinical study titled "Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients". The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

What is the current status of trial NCT03617445?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-08-03. Estimated completion is 2023-06-01.

What interventions are being tested in trial NCT03617445?

The interventions under investigation include: Oral Vancomycin (DRUG), FMT oral capsule (DRUG), FMT oral placebo (DRUG), Oral Vancomycin placebo (DRUG).

Who is sponsoring clinical trial NCT03617445?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03617445's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03617445, the US trial registry maintained by the National Library of Medicine. NCT03617445 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.