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

Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01091558

Enrollment

204

Registered

2010-03-24

Start date

2009-09-30

Completion date

2011-12-31

Last updated

2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Ulcerative Colitis

Keywords

ulcerative colitis, colon cancer, endoscopy, screening

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Exclusion criteria

* refusal to participate * age less than 18 years at time of colonoscopy

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results