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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00573846
• Other study ID #: OCRT07005
• Secondary ID: 2007-5807
• Status: Withdrawn
• Phase: N/A
• First received: December 12, 2007
• Last updated: January 26, 2015
• Start date: July 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2015
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with origins from the Indian sub-continent

• Patients will be selected from the IBD registry maintained at respective institutions.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (6)

Lead Sponsor	Collaborator
University of California, Irvine	Jefferson Medical College of Thomas Jefferson University, Mayo Clinic, Texas Health Resources, University of Kentucky, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenotypic characteristics of inflammatory bowel disease in southeast asian population	Retrospective chart review	12 months	No