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NCT02053350 · ClinicalTrials.gov registry record · Phase 2

Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection

A Phase 2 study, sponsored by University of Virginia.

Terminated
Registry status
Phase 2
Development phase
7
Enrollment target

NCT02053350: Clinical Trial Phase 2 study, sponsored by University of Virginia.

NCT02053350 is a Phase 2 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02053350, a Phase 2 study, was terminated before completion, sponsored by University of Virginia.

TERMINATED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study Summary

The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality and recurrent disease.

Primary Outcome

Day 40 clinical failure - clinical failure includes death or CDI recurrence assessed 40 days post randomization or lack of clinical cure

Interventions

  • DRUG Alanyl-glutamine

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2015-04
Est. Completion 2017-04-05
Phase Phase 2
University of Virginia

449 total trials

Why NCT02053350 stopped before completion

NCT02053350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

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

NCT02053350 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02053350 about?

NCT02053350 is a clinical study titled "Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection". The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality and recurrent disease.

What is the current status of trial NCT02053350?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2015-04. Estimated completion is 2017-04-05.

What interventions are being tested in trial NCT02053350?

The interventions under investigation include: Alanyl-glutamine (DRUG).

Who is sponsoring clinical trial NCT02053350?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02053350's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 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 NCT02053350, the US trial registry maintained by the National Library of Medicine. NCT02053350 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.