L-glutamine Treatment in Patients With Diverticulosis

NCT ID: NCT05106101

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2022-12-30

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)

Conditions

Diverticulosis, Colonic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L-glutamine

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

Group Type: EXPERIMENTAL

L-glutamine

Intervention Type: DRUG

L-glutamine oral powder in 5 gram packet

Interventions

L-glutamine

L-glutamine oral powder in 5 gram packet

Intervention Type: DRUG

Other Intervention Names

oral L-glutamine

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emmaus Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yutaka L Niihara, MD

Role: STUDY_CHAIR

Emmaus Medical, Inc.

Locations

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

Countries

United States

Other Identifiers

EM-DsD-002

Identifier Type: -

Identifier Source: org_study_id