L-glutamine Treatment in Patients With Diverticulosis

Diverticulosis, Colonic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106101
• Other study ID #: EM-DsD-002
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: Emmaus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diverticulosis, Colonic
• Diverticulum

Intervention

Drug:
• L-glutamine
L-glutamine oral powder in 5 gram packet

Locations

Country	Name	City	State
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	The Lundquist Institute at Harbor-UCLA Medical Center	Torrance	California
United States	Ventura Clinical Trials	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Emmaus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 6 months and 12 months
Secondary	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	Baseline, 6 month and 12 months
Secondary	Effect of oral L-glutamine on Hematological Parameters - Hemoglobin	Patient's hemoglobin will be collected at each visit	Baseline to 48 weeks (12 months)
Secondary	Effect of oral L-glutamine on Hematological Parameters - Hematocrit	Patient's hematocrit will be collected at each visit	Baseline to 48 weeks (12 months)
Secondary	Effect of oral L-glutamine on Vital Signs - Blood Pressure	Patient's blood pressure will be collected at each visit	Baseline to 48 weeks (12 months)
Secondary	Effect of oral L-glutamine on Vital Signs - Pulse Rate	Patient's pulse rate will be collected at each visit	Baseline to 48 weeks (12 months)
Secondary	Effect of oral L-glutamine on Vital Signs - Temperature	Patient's temperature will be collected at each visit	Baseline to 48 weeks (12 months)
Secondary	Effect of oral L-glutamine on Vital Signs - Respiration	Patient's respiration will be collected at each visit	Baseline to 48 weeks (12 months)