L-glutamine Treatment in Patients With Diverticulosis

February 15, 2023 updated by: Emmaus Medical, Inc.

A Pilot/Phase 1, Interventional, Open-label, Multi-center Study to Assess the Safety and Efficacy of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • The Lundquist Institute at Harbor-UCLA Medical Center
      • Ventura, California, United States, 93003
        • Ventura Clinical Trials
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: L-glutamine
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
Drug: L-glutamine
L-glutamine oral powder in 5 gram packet
Other Names:
  • oral L-glutamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 month and 12 months
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
Baseline to 48 weeks (12 months)
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
Baseline to 48 weeks (12 months)
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
Baseline to 48 weeks (12 months)
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
Baseline to 48 weeks (12 months)
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
Baseline to 48 weeks (12 months)
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
Baseline to 48 weeks (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emmaus Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yutaka L Niihara, MD, Emmaus Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EM-DsD-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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