Back to resultsL-glutamine Treatment in Patients With Diverticulosis
Primary Purpose
Diverticulosis, Colonic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-glutamine
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulosis, Colonic
Eligibility Criteria
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.
Sites / Locations
- The Lundquist Institute at Harbor-UCLA Medical Center
- Ventura Clinical Trials
- Clinical Trials of Texas, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
L-glutamine
Arm Description
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis
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
Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
Patient's hemoglobin will be collected at each visit
Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Patient's hematocrit will be collected at each visit
Effect of oral L-glutamine on Vital Signs - Blood Pressure
Patient's blood pressure will be collected at each visit
Effect of oral L-glutamine on Vital Signs - Pulse Rate
Patient's pulse rate will be collected at each visit
Effect of oral L-glutamine on Vital Signs - Temperature
Patient's temperature will be collected at each visit
Effect of oral L-glutamine on Vital Signs - Respiration
Patient's respiration will be collected at each visit
Full Information
NCT ID
NCT05106101
First Posted
September 22, 2021
Last Updated
February 15, 2023
Sponsor
Emmaus Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05106101
Brief Title
L-glutamine Treatment in 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emmaus Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulosis, Colonic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-glutamine
Arm Type
Experimental
Arm Description
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
L-glutamine
Other Intervention Name(s)
oral L-glutamine
Intervention Description
L-glutamine oral powder in 5 gram packet
Primary Outcome Measure Information:
Title
Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
Description
Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months
Time Frame
Baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis
Description
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
Time Frame
Baseline, 6 month and 12 months
Title
Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
Description
Patient's hemoglobin will be collected at each visit
Time Frame
Baseline to 48 weeks (12 months)
Title
Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Description
Patient's hematocrit will be collected at each visit
Time Frame
Baseline to 48 weeks (12 months)
Title
Effect of oral L-glutamine on Vital Signs - Blood Pressure
Description
Patient's blood pressure will be collected at each visit
Time Frame
Baseline to 48 weeks (12 months)
Title
Effect of oral L-glutamine on Vital Signs - Pulse Rate
Description
Patient's pulse rate will be collected at each visit
Time Frame
Baseline to 48 weeks (12 months)
Title
Effect of oral L-glutamine on Vital Signs - Temperature
Description
Patient's temperature will be collected at each visit
Time Frame
Baseline to 48 weeks (12 months)
Title
Effect of oral L-glutamine on Vital Signs - Respiration
Description
Patient's respiration will be collected at each visit
Time Frame
Baseline to 48 weeks (12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutaka L Niihara, MD
Organizational Affiliation
Emmaus Medical, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
The Lundquist Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
L-glutamine Treatment in Patients With Diverticulosis
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