CompletedPhase 1

L-glutamine Treatment in Patients With Diverticulosis

United States9 participantsStarted 2019-07-19

Plain-language summary

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

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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.

✕. 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).

Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.

Timeframe: Baseline, 6 months and 12 months

NCT IDNCT05106101

SponsorEmmaus Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-30