L-glutamine Treatment in Patients With Diverticulosis

NCT05106101 | Completed Phase 1 FDA Drug

• 1 other identifier: EM-DsD-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diverticulosis, Colonic

Outcome Measures

Primary Outcomes (1)

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

  Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months

  Baseline, 6 months and 12 months

Secondary Outcomes (7)

• 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

• Effect of oral L-glutamine on Hematological Parameters - Hemoglobin

  Baseline to 48 weeks (12 months)

• Effect of oral L-glutamine on Hematological Parameters - Hematocrit

  Baseline to 48 weeks (12 months)

• Effect of oral L-glutamine on Vital Signs - Blood Pressure

  Baseline to 48 weeks (12 months)

• Effect of oral L-glutamine on Vital Signs - Pulse Rate

  Baseline to 48 weeks (12 months)

Study Arms (1)

L-glutamine

EXPERIMENTAL

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

Drug: L-glutamine

Interventions

L-glutamine DRUG

L-glutamine oral powder in 5 gram packet

Also known as: oral L-glutamine

L-glutamine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Emmaus Medical, Inc.: lead

Study Sites (3)

The Lundquist Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diverticulosis, Colonic

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Yutaka L Niihara, MD

  Emmaus Medical, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 3, 2021
• Study Start: July 19, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 16, 2023

Record last verified: 2022-11

Locations

US (3)