Trial · NCT01414244
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
NCT01414244, Phase 2, Completed, Tulane University; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glutamine for the Treatment of Patients With Irritable Bowel Syndrome. Trials, record NCT01414244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01414244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
- NCT number
- NCT01414244
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 106 participants, actual
- Lead sponsor
- Tulane University
- Conditions
- Diarrhea-Predominant Irritable Bowel Syndrome
- Interventions
- Glutamine
- First posted
- 2011-08-11
- Last updated
- 2017-08-09
- Results first posted
- 2017-08-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Irritable Bowel Symptom Severity Scale | baseline and 8 weeks following therapy | 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. |
| Secondary | Intestinal Permeability | baseline and 8 weeks following therapy | The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol. |
| Secondary | Stool Frequency | Baseline and 8 weeks following therapy | Baseline and 8 week at the conclusion of therapy |
| Secondary | Stool Consistency | Baseline and 8 weeks following therapy | Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Irritable Bowel Symptom Severity Scale | baseline and 8 weeks following therapy | units on a scale | MEAN | |
| SECONDARY | Intestinal Permeability | baseline and 8 weeks following therapy | lactulose/mannitol (L/M) | MEAN | |
| SECONDARY | Stool Frequency | Baseline and 8 weeks following therapy | stools per day | MEAN | |
| SECONDARY | Stool Consistency | Baseline and 8 weeks following therapy | units on a scale (1-7) | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Irritable Bowel Symptom Severity Scale | Glutamine | 181 | Standard Deviation 48 | units on a scale | |
| Change in the Irritable Bowel Symptom Severity Scale | Placebo | 301 | Standard Deviation 57 | units on a scale | |
| Intestinal Permeability | Glutamine | 0.05 | Standard Deviation 0.01 | lactulose/mannitol (L/M) | |
| Intestinal Permeability | Placebo | 0.10 | Standard Deviation 0.03 | lactulose/mannitol (L/M) | |
| Stool Frequency | Glutamine | 2.9 | Standard Deviation 0.9 | stools per day | |
| Stool Frequency | Placebo | 5.3 | Standard Deviation 2.1 | stools per day | |
| Stool Consistency | Glutamine | 3.9 | Standard Deviation 1.2 | units on a scale (1-7) | |
| Stool Consistency | Placebo | 6.6 | Standard Deviation 0.53 | units on a scale (1-7) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glutamine | 54 | |
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | COMPLETED | Glutamine | 54 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | NOT COMPLETED | Glutamine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glutamine | 0 | 54 |
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, other adverse events | Glutamine | 0 | 54 |
| Total, other adverse events | Placebo | 0 | 52 |
| Total, serious adverse events | Glutamine | 0 | 54 |
| Total, serious adverse events | Placebo | 0 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30108163 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Glutamine vs Placebo: deaths from any cause | Trial comparisons |
| Glutamine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01414244
GET https://conductscience.org/api/trials/v1/NCT01414244/registered