- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05106101
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
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
Interventional
Enrollment (Actual)
9
Phase
- 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
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California
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Torrance, California, United States, 90502
- The Lundquist Institute at Harbor-UCLA Medical Center
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Ventura, California, United States, 93003
- Ventura Clinical Trials
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Texas
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, Inc.
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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
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 |
Intervention / Treatment |
---|---|
Experimental: L-glutamine
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
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L-glutamine oral powder in 5 gram packet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months
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Baseline, 6 months and 12 months
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Secondary Outcome Measures
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
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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
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Baseline, 6 month and 12 months
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Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
Time Frame: Baseline to 48 weeks (12 months)
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Patient's hemoglobin will be collected at each visit
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Baseline to 48 weeks (12 months)
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Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Time Frame: Baseline to 48 weeks (12 months)
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Patient's hematocrit will be collected at each visit
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Baseline to 48 weeks (12 months)
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Effect of oral L-glutamine on Vital Signs - Blood Pressure
Time Frame: Baseline to 48 weeks (12 months)
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Patient's blood pressure will be collected at each visit
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Baseline to 48 weeks (12 months)
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Effect of oral L-glutamine on Vital Signs - Pulse Rate
Time Frame: Baseline to 48 weeks (12 months)
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Patient's pulse rate will be collected at each visit
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Baseline to 48 weeks (12 months)
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Effect of oral L-glutamine on Vital Signs - Temperature
Time Frame: Baseline to 48 weeks (12 months)
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Patient's temperature will be collected at each visit
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Baseline to 48 weeks (12 months)
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Effect of oral L-glutamine on Vital Signs - Respiration
Time Frame: Baseline to 48 weeks (12 months)
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Patient's respiration will be collected at each visit
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Baseline to 48 weeks (12 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
July 19, 2019
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
September 22, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 3, 2021
Study Record Updates
Last Update Posted (Actual)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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