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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Keith Wilson, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT01091558
First received: March 18, 2010
Last updated: March 30, 2017
Last verified: March 2017
  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 Keith Wilson, Vanderbilt University Medical Center:

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 ]

Secondary Outcome Measures:
  • L-Arg intake in the diet of UC patients and control subjects [ Time Frame: 24 months ]

Biospecimen Retention:   Samples Without DNA
blood, urine and tissue

Enrollment: 204
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Keith Wilson, MD, AGAF Vanderbilt University Medical Center
  More Information

Responsible Party: Keith Wilson, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01091558     History of Changes
Other Study ID Numbers: 090943
3R01AT004821-02S1 ( US NIH Grant/Contract Award Number )
Study First Received: March 18, 2010
Last Updated: March 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Keith Wilson, Vanderbilt University Medical Center:
ulcerative colitis
colon cancer
endoscopy
screening

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

ClinicalTrials.gov processed this record on June 23, 2017