Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Pilot/Phase 1, Interventional, Open-label, Multi-center Study to Assess the Safety and Efficacy of L-glutamine Treatment in Patients With Diverticulosis

Details

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)

Keywords

Diverticulosis, Colonic Diverticulum Diverticular Diseases L-glutamine

Eligibility

You can join if…

Open to people ages 50 years and up

  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.

You CAN'T join if...

  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.

Locations

  • The Lundquist Institute at Harbor-UCLA Medical Center
    Torrance California 90502 United States
  • Ventura Clinical Trials
    Ventura California 93003 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Emmaus Medical, Inc.
ID
NCT05106101
Phase
Phase 1 Diverticulosis, Colonic Research Study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated