Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-Centered US Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Kentucky
University of Texas Southwestern Medical Center
Texas Health Resources
Mayo Clinic
Jefferson Medical College of Thomas Jefferson University
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573846
First received: December 12, 2007
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

This is a retrospective, case control study of inflammatory bowel disease. This study will analyze the phenotypic characteristics of inflammatory bowel disease in the Southeast Asian population and will help describe clinical characteristics and serologic profiles in Southeast Asians with inflammatory bowel disease, comparing the phenotype differences to historical Caucasian controls. The data from this study will help identify the phenotype characteristics of different ethnic groups and study the epidemiological patterns of the disease.


Condition
Inflammatory Bowel Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-Centered US Study

Further study details as provided by University of California, Irvine:

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: July 2008
Detailed Description:

This study is a retrospective, case control study of inflammatory bowel disease characteristics in patients with origins from the Indian sub-continent. Patients will be selected from the IBD registry maintained at respective institutions. Subjects from the Indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the United States.

Using both electronic and paper databases, demographic information regarding age, gender, body mass index, smoking history, dietary habits; medical history such as type of IBD, IBD symptoms, location and behavior, medication use (past and current), history of other autoimmune disorders; surgical history (IBD and non-IBD related); laboratory indices such as IBD serology, Thiopurinemethyltransferase (TPMT), and infliximab levels will be collected.

Demographics will be compared between groups using descriptive statistics. Using univariate analysis, variables that are significantly different will be identified. Conditional logistic regression will then be performed to identify those clinical variables that are statistically significant.

The study duration will be one year from IRB approval.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients will be selected from the IBD registry maintained at respective institutions. Subjects from the Indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the United States.

Criteria

Inclusion Criteria:

  • Patients with origins from the Indian sub-continent
  • Patients will be selected from the IBD registry maintained at respective institutions.
  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: NCT00573846

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
University of Kentucky
University of Texas Southwestern Medical Center
Texas Health Resources
Mayo Clinic
Jefferson Medical College of Thomas Jefferson University
Investigators
Principal Investigator: Nimisha K Parekh, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Nimisha K. Parekh, M.D., University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573846     History of Changes
Other Study ID Numbers: OCRT07005, 2007-5807
Study First Received: December 12, 2007
Last Updated: December 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
IBD

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014