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Completed

NCT Number: NCT05106101

L-glutamine Treatment in Patients With Diverticulosis

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

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Key information

Conditions

Diverticulosis, Colonic Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

  • 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.

Treatment and study plan

L-glutamine

Drug

L-glutamine oral powder in 5 gram packet

Other names: oral L-glutamine

Primary outcomes

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

    Time frame: Baseline, 6 months and 12 months

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

Secondary outcomes

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

    Time frame: Baseline, 6 month and 12 months

    Size of diverticula at the descending and sigmoid colon will be estimated as small only, large only, or both small and large, where large is defined as greater than 7 mm in diameter

  2. Effect of oral L-glutamine on Hematological Parameters - Hemoglobin

    Time frame: Baseline to 48 weeks (12 months)

    Patient's hemoglobin will be collected at each visit

  3. Effect of oral L-glutamine on Hematological Parameters - Hematocrit

    Time frame: Baseline to 48 weeks (12 months)

    Patient's hematocrit will be collected at each visit

  4. Effect of oral L-glutamine on Vital Signs - Blood Pressure

    Time frame: Baseline to 48 weeks (12 months)

    Patient's blood pressure will be collected at each visit

  5. Effect of oral L-glutamine on Vital Signs - Pulse Rate

    Time frame: Baseline to 48 weeks (12 months)

    Patient's pulse rate will be collected at each visit

  6. Effect of oral L-glutamine on Vital Signs - Temperature

    Time frame: Baseline to 48 weeks (12 months)

    Patient's temperature will be collected at each visit

  7. Effect of oral L-glutamine on Vital Signs - Respiration

    Time frame: Baseline to 48 weeks (12 months)

    Patient's respiration will be collected at each visit

Sponsors and collaborators

Lead sponsor

Emmaus Medical, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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