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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.
In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine supplementation | Active Comparator | Glutamine |
|
| Placebo | Placebo Comparator | Whey protein powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Drug | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Irritable Bowel Symptom Severity Scale | 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. | baseline and 8 weeks following therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Permeability | 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. | baseline and 8 weeks following therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| QiQi Zhou | Tulane University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30108163 | Derived | Zhou Q, Verne ML, Fields JZ, Lefante JJ, Basra S, Salameh H, Verne GN. Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome. Gut. 2019 Jun;68(6):996-1002. doi: 10.1136/gutjnl-2017-315136. Epub 2018 Aug 14. |
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Some data will be available through publications, however further plans to make all IPD available is unknown.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glutamine | Oral Glutamine Powder |
| FG001 | Placebo | Oral Whey Protein Powder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glutamine | Oral Glutamine Powder |
| BG001 | Placebo | Oral Whey Protein Powder |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Irritable Bowel Symptom Severity Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks following therapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glutamine | Oral Glutamine Powder | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| QiQi Zhou | Tulane University | 988-7800 | qiqi06@gmail.com |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Stool Frequency |
Baseline and 8 week at the conclusion of therapy |
| Baseline and 8 weeks following therapy |
| Stool Consistency | 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. | Baseline and 8 weeks following therapy |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Intestinal Permeability | 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. | Posted | Mean | Standard Deviation | lactulose/mannitol (L/M) | baseline and 8 weeks following therapy |
|
|
|
| Secondary | Stool Frequency | Baseline and 8 week at the conclusion of therapy | Posted | Mean | Standard Deviation | stools per day | Baseline and 8 weeks following therapy |
|
|
|
| Secondary | Stool Consistency | 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. | Posted | Mean | Standard Deviation | units on a scale (1-7) | Baseline and 8 weeks following therapy |
|
|
|
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Placebo | Oral Whey Protein Powder | 0 | 52 | 0 | 52 | 0 | 52 |
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| D004066 | Digestive System Diseases |
| D021542 | Amino Acids, Neutral |