L-glutamine Treatment in Patients With Diverticulosis

Completed · Phase 1

Conditions studied: Diverticulosis, Colonic

In brief

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

Key facts

Study ID

NCT05106101

Run by

Emmaus Medical, Inc.

People needed

9

Starts

2019-07-19

Expected to finish

2022-12-30

Last updated by the study team

2023-02-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥50 years of age.
• Uncomplicated diverticulosis confirmed by colonoscopy.
• 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.)
• 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).
• Patients who have given their free and written informed consent.

You may not qualify if…

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

Where it is running

• The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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