L-glutamine Treatment in Patients With Diverticulosis

Study Overview
=================
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)

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

Conditions
-----------------
Diverticulosis, Colonic

Intervention / Treatment
-----------------
* Drug: L-glutamine


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-glutamine<br>Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks | Drug: L-glutamine<br>* L-glutamine oral powder in 5 gram packet<br>* Other names: oral L-glutamine;|

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. | 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

| 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 | 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 | Patient's hemoglobin will be collected at each visit | Baseline to 48 weeks (12 months) | 
| Effect of oral L-glutamine on Hematological Parameters - Hematocrit | 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 | 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 | 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 | Patient's temperature will be collected at each visit | Baseline to 48 weeks (12 months) | 
| Effect of oral L-glutamine on Vital Signs - Respiration | Patient's respiration will be collected at each visit | Baseline to 48 weeks (12 months) |