L-glutamine Treatment in Patients With Diverticulosis
Study Details
Study Description
Brief Summary
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: L-glutamine Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks |
Drug: L-glutamine
L-glutamine oral powder in 5 gram packet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis. [Baseline, 6 months and 12 months]
Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months
Secondary Outcome Measures
- Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis [Baseline, 6 month and 12 months]
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
- Effect of oral L-glutamine on Hematological Parameters - Hemoglobin [Baseline to 48 weeks (12 months)]
Patient's hemoglobin will be collected at each visit
- Effect of oral L-glutamine on Hematological Parameters - Hematocrit [Baseline to 48 weeks (12 months)]
Patient's hematocrit will be collected at each visit
- Effect of oral L-glutamine on Vital Signs - Blood Pressure [Baseline to 48 weeks (12 months)]
Patient's blood pressure will be collected at each visit
- Effect of oral L-glutamine on Vital Signs - Pulse Rate [Baseline to 48 weeks (12 months)]
Patient's pulse rate will be collected at each visit
- Effect of oral L-glutamine on Vital Signs - Temperature [Baseline to 48 weeks (12 months)]
Patient's temperature will be collected at each visit
- Effect of oral L-glutamine on Vital Signs - Respiration [Baseline to 48 weeks (12 months)]
Patient's respiration will be collected at each visit
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥50 years of age.
-
Uncomplicated diverticulosis confirmed by colonoscopy.
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Colonoscopy indicates ≥5 colonic diverticula (pouches) in the descending/sigmoid colon and < approximately10 colonic diverticula (pouches) per segment (e.g. proximal descending, distal descending, proximal sigmoid, and distal sigmoid.)
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If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence).
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Patients who have given their free and written informed consent.
Exclusion Criteria:
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Acute diverticulitis (both complicated and uncomplicated).
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Acute colitis
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History of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation.
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Active bleeding
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More than 40 diverticula
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Chronic renal insufficiency
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Chronic liver disease.
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Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female of childbearing potential).
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Inability to give a valid informed consent or to properly follow the protocol.
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Patients with an active malignancy of any type, or a recent history of malignancy within the last 5 years.
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Treated with an investigational medication/treatment within 30 days prior to the screening visit.
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Currently enrolled in an Investigational study
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Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit.
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Previous difficulty pulling or passing of scope or difficulty completing colonoscopy.
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There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Lundquist Institute at Harbor-UCLA Medical Center | Torrance | California | United States | 90502 |
| 2 | Ventura Clinical Trials | Ventura | California | United States | 93003 |
| 3 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Emmaus Medical, Inc.
Investigators
- Study Chair: Yutaka L Niihara, MD, Emmaus Medical, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EM-DsD-002