Clinical trial NCT05106101: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diverticulosis, Colonic
Lead sponsor: Emmaus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis
timeFrame: Baseline, 6 month and 12 months
measure: Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
timeFrame: Baseline to 48 weeks (12 months)
measure: Effect of oral L-glutamine on Hematological Parameters - Hematocrit
timeFrame: Baseline to 48 weeks (12 months)
measure: Effect of oral L-glutamine on Vital Signs - Blood Pressure
timeFrame: Baseline to 48 weeks (12 months)
measure: Effect of oral L-glutamine on Vital Signs - Pulse Rate
timeFrame: Baseline to 48 weeks (12 months)
measure: Effect of oral L-glutamine on Vital Signs - Temperature
timeFrame: Baseline to 48 weeks (12 months)
measure: Effect of oral L-glutamine on Vital Signs - Respiration
timeFrame: Baseline to 48 weeks (12 months)
Other outcomes:
Locations:
city: Torrance
country: United States
facility: The Lundquist Institute at Harbor-UCLA Medical Center
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Emmaus Medical, Inc.
name: Yutaka L Niihara, MD
role: STUDY_CHAIR
References: