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NCT04305769 · ClinicalTrials.gov registry record · Phase 2

Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)

A Phase 2 study of Clostridium Difficile Infection and Clostridioides Difficile Infection, sponsored by University of Virginia.

Recruiting
Registry status
Phase 2
Development phase
260
Enrollment target
2
Study locations

NCT04305769 is a Phase 2 study of Clostridium Difficile Infection and Clostridioides Difficile Infection that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 260 participants, below the 12,046-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT04305769, a Phase 2 study of Clostridium Difficile Infection and Clostridioides Difficile Infection, is actively recruiting participants, sponsored by University of Virginia.

RECRUITING
Registry status
Phase 2
Development phase
260 participants
Enrollment target
2
Study locations

Study Summary

This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. The investigators hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.

Conditions Studied

Clostridium Difficile Infection Clostridioides Difficile Infection Clostridium Difficile Diarrhea Clostridia Difficile Colitis

Interventions

  • DRUG Alanyl-glutamine

Study Locations (2)

Virginia

  • UVA Health Systems - Charlottesville
  • Carilion Clinic - Roanoke

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2021-06-01
Est. Completion 2027-06-30
Phase Phase 2

Sponsor

University of Virginia

449 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04305769

The ClinicalTrials.gov registry entry for NCT04305769 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,046-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 1 intervention - of which Alanyl-glutamine is the first listed.

NCT04305769 reports 2 study locations spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT04305769 about?

NCT04305769 is a clinical study titled "Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)". This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, o...

What is the current status of trial NCT04305769?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2021-06-01. Estimated completion is 2027-06-30.

What conditions does trial NCT04305769 study?

This clinical trial studies the following conditions: Clostridium Difficile Infection, Clostridioides Difficile Infection, Clostridium Difficile Diarrhea, Clostridia Difficile Colitis.

What interventions are being tested in trial NCT04305769?

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

Who is sponsoring clinical trial NCT04305769?

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

Where is trial NCT04305769 being conducted?

This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.