Study of Effects of L-Arginine in Colitis and Colon Cancer

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01091558

Collaborator

National Institutes of Health (NIH) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)

204

Enrollment

Location

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell.

The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Colon Cancer

Detailed Description

Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (HPLC). Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (PCR) analysis of mRNA expression.

Study Design

Study Type:

Observational

Actual Enrollment :

204 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Colonoscopy Healthy volunteer who is having a screening colonoscopy
Ulcerative Colitis Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons.

Outcome Measures

Primary Outcome Measures

L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity [24 months]

Secondary Outcome Measures

L-Arg intake in the diet of UC patients and control subjects [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years of age or older
Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis)
Screening for cancer