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The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4 weeks screening period to determine eligibility for study entry. At Week 0, patients who meet eligibility requirements will be given L-glutamine (15 grams, twice daily)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-glutamine | Experimental | Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-glutamine | Drug | L-glutamine oral powder in 5 gram packet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis. | Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months | Baseline, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis | Size of diverticula at the descending and sigmoid colon will be estimated as small only, large only, or both small and large, where large is defined as greater than 7 mm in diameter | Baseline, 6 month and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yutaka L Niihara, MD | Emmaus Medical, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Lundquist Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States | ||
| Ventura Clinical Trials |
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| ID | Term |
|---|---|
| D043963 | Diverticulosis, Colonic |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System 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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| Effect of oral L-glutamine on Hematological Parameters - Hemoglobin |
Patient's hemoglobin will be collected at each visit |
| Baseline to 48 weeks (12 months) |
| Effect of oral L-glutamine on Hematological Parameters - Hematocrit | Patient's hematocrit will be collected at each visit | Baseline to 48 weeks (12 months) |
| Effect of oral L-glutamine on Vital Signs - Blood Pressure | Patient's blood pressure will be collected at each visit | Baseline to 48 weeks (12 months) |
| Effect of oral L-glutamine on Vital Signs - Pulse Rate | Patient's pulse rate will be collected at each visit | Baseline to 48 weeks (12 months) |
| Effect of oral L-glutamine on Vital Signs - Temperature | Patient's temperature will be collected at each visit | Baseline to 48 weeks (12 months) |
| Effect of oral L-glutamine on Vital Signs - Respiration | Patient's respiration will be collected at each visit | Baseline to 48 weeks (12 months) |
| Ventura |
| California |
| 93003 |
| United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| D021542 | Amino Acids, Neutral |