This trial is active, not recruiting.

Conditions ulcerative colitis, colon cancer
Sponsor Vanderbilt University
Collaborator National Institutes of Health (NIH)
Start date September 2009
End date September 2011
Trial size 200 participants
Trial identifier NCT01091558, 090943, 3R01AT004821-02S1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Healthy volunteer who is having a screening colonoscopy
Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons.

Primary Outcomes

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

Secondary Outcomes

L-Arg intake in the diet of UC patients and control subjects
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer
Principal investigator Keith Wilson, MD, AGAF
Description Amino acids are being measured in colon tissues and in serum by 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 PCR analysis of mRNA expression.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.