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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: Recruiting Phase 2 study of Clostridium Difficile Infection and Clostridioides Difficile Infection, sponsored by University of Virginia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Documented C difficile infection defined by presence of recurrent diarrhea with stool positive for C difficile assay necessitating treatment with anti-C. difficile antibiotic.
Conditions Studied
Interventions
- DRUG Alanyl-glutamine
Study Locations (2)
Virginia
- UVA Health Systems - Charlottesville
- Carilion Clinic - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT04305769 shows while recruiting
NCT04305769 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 12,046-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04305769's enrollment target sits among peer trials
260 6th of 13 higher than 8 of 13 other Clostridium Difficile Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clostridium Difficile Infection 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.
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