L-glutamine Treatment in Patients With Diverticulosis

Emmaus Medical

Status and phase: Completed; Phase 1

Conditions: Diverticulosis, Colonic

Treatments: Drug: L-glutamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05106101

EM-DsD-002

Details and patient eligibility

About

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

Full 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)

Enrollment: 9 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

L-glutamine

Experimental group

Description:

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

Treatment:

Drug: L-glutamine