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NCT01414244 · ClinicalTrials.gov registry record · Phase 2
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
A Phase 2 study of Diarrhea-Predominant Irritable Bowel Syndrome, sponsored by Tulane University.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT01414244: Completed Phase 2 study of Diarrhea-Predominant Irritable Bowel Syndrome, sponsored by Tulane University.
NCT01414244 is a Phase 2 study of Diarrhea-Predominant Irritable Bowel Syndrome that has completed, run by Tulane University. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01414244, a Phase 2 study of Diarrhea-Predominant Irritable Bowel Syndrome, has completed, sponsored by Tulane University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.
Primary Outcome
The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.
Conditions Studied
Interventions
- DRUG Glutamine
Study Locations (1)
Louisiana
- Tulane University School of Medicine - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-12-30 |
| Phase | Phase 2 |
What the finished NCT01414244 record still lists
NCT01414244 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Diarrhea-Predominant Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Glutamine is the first listed.
NCT01414244 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT01414244 about?
NCT01414244 is a clinical study titled "Glutamine for the Treatment of Patients With Irritable Bowel Syndrome". New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who ...
What is the current status of trial NCT01414244?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2010-11. Estimated completion is 2015-12-30.
What conditions does trial NCT01414244 study?
This clinical trial studies the following conditions: Diarrhea-Predominant Irritable Bowel Syndrome.
What interventions are being tested in trial NCT01414244?
The interventions under investigation include: Glutamine (DRUG).
Who is sponsoring clinical trial NCT01414244?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01414244 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01414244's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 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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