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NCT02748616 · ClinicalTrials.gov registry record · Phase 4

C. Difficile and Ursodiol

A Phase 4 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
9
Enrollment target

NCT02748616: Completed Phase 4 study, sponsored by NYU Langone Health.

NCT02748616 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02748616, a Phase 4 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
9 participants
Enrollment target

Study Summary

In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.

Interventions

  • DRUG Ursodiol

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2017-03-01
Est. Completion 2020-01-31
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT02748616 record still lists

NCT02748616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Ursodiol is the first listed.

NCT02748616 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02748616 about?

NCT02748616 is a clinical study titled "C. Difficile and Ursodiol". In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), an...

What is the current status of trial NCT02748616?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2017-03-01. Estimated completion is 2020-01-31.

What interventions are being tested in trial NCT02748616?

The interventions under investigation include: Ursodiol (DRUG).

Who is sponsoring clinical trial NCT02748616?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02748616's enrollment target sits among peer trials

9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT02748616, the US trial registry maintained by the National Library of Medicine. NCT02748616 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.