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

Completed
Conditions
Colon Cancer
Ulcerative Colitis
Registration Number
NCT01091558
Lead Sponsor
Vanderbilt University Medical Center
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
204
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
Exclusion Criteria
  • refusal to participate
  • age less than 18 years at time of colonoscopy

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity24 months
Secondary Outcome Measures
NameTimeMethod
L-Arg intake in the diet of UC patients and control subjects24 months

Trial Locations

Locations (1)

Vanderbilt Hospital

🇺🇸

Nashville, Tennessee, United States

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