L-glutamine Treatment in Patients With Diverticulosis

Phase 1

Completed

• Conditions: Diverticulosis, Colonic
• Interventions: Drug: L-glutamine

• Registration Number: NCT05106101
• Lead Sponsor: Emmaus Medical, Inc.

Brief Summary

The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.

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 Timeline

• Study Start: 2019-07-19
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-03
• Status Verified: 2022-11
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. ≥50 years of age.
2. Uncomplicated diverticulosis confirmed by colonoscopy.
3. 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.)
4. 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).
5. Patients who have given their free and written informed consent.

Exclusion Criteria

1. Acute diverticulitis (both complicated and uncomplicated).
2. Acute colitis
3. History of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation.
4. Active bleeding
5. More than 40 diverticula
6. Chronic renal insufficiency
7. Chronic liver disease.
8. Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female of childbearing potential).
9. Inability to give a valid informed consent or to properly follow the protocol.
10. Patients with an active malignancy of any type, or a recent history of malignancy within the last 5 years.
11. Treated with an investigational medication/treatment within 30 days prior to the screening visit.
12. Currently enrolled in an Investigational study
13. Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit.
14. Previous difficulty pulling or passing of scope or difficulty completing colonoscopy.
15. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L-glutamine	L-glutamine	Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 - Temperature	Baseline to 48 weeks (12 months)	Patient's temperature 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 - Respiration	Baseline to 48 weeks (12 months)	Patient's respiration will be collected at each visit

Trial Locations

Locations (3)

The Lundquist Institute at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

Ventura Clinical Trials; 🇺🇸 Ventura, California, United States