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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Keith Wilson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01091558
First received: March 18, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Ulcerative Colitis
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • L-Arg intake in the diet of UC patients and control subjects [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood, urine and tissue


Estimated Enrollment: 200
Study Start Date: September 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colonoscopy
Healthy volunteer who is having a screening colonoscopy
Ulcerative Colitis
Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Any patient scheduled to have a colonoscopy as part of medical care for either ulcerative colitis or as a routine screening colonoscopy.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091558

Locations
United States, Tennessee
Vanderbilt Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Keith Wilson, MD, AGAF Vanderbilt University
  More Information

No publications provided

Responsible Party: Keith Wilson, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01091558     History of Changes
Other Study ID Numbers: 090943, 3R01AT004821-02S1
Study First Received: March 18, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board
United States: Data Monitoring Committee Vanderbilt University

Keywords provided by Vanderbilt University:
ulcerative colitis
colon cancer
endoscopy
screening

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Colonic Neoplasms
Ulcer
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014