Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)

Inflammatory Bowel Disease Clinical Trial

— MAAIS  

Official title:

Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01169194
• Other study ID #: NA_00041578
• Secondary ID: U01DK062431
• Status: Recruiting
• Start date: June 2003
• Est. completion date: August 2027

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: Lisa Datta, MS
• Phone: 410-502-0040
• Email: ibd[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population. African Americans with or without Crohn's disease or ulcerative colitis are eligible to join. If you agree to join the study, the investigators will ask for information about your health. The investigators will also ask you to give us a blood sample so that they may discover the genes that cause IBD. The blood sample may be collected at Johns Hopkins or any local facility convenient to you.

Description:

This current protocol was established as part of an NIDDK initiative to further explore genetic factors associated with IBD. Specifically, the investigators are interested in identifying the genetic, environment and socio-economical components that contribute to the development of IBD in the African American population. IBD is believed to be caused by a combination of environmental and genetic factors. Genetic data will be examined alongside potential environmental factors such as smoking, medications, environmental exposures, and some dietary factors. Since IBD is known to predominantly affect Western, industrialized areas of the world, the investigators will also inquire about participants' socioeconomic background in hopes of identifying any previously unknown factors in the AA population that may increase the risk of IBD. These potential environmental factors will be important in association analyses using covariates as these factors can obscure potential associations or interact with genetic factors and thus contribute to genetic associations. The investigators will also obtain information as to ancestry of parents and grandparents as to best match cases with unrelated controls of similar ancestry (e.g., Caribbean, recent European or recent African ancestry could cause genetic mismatch of a case and control). At the same time, the investigators will also collect similar information (smoking, medications, environmental exposures and dietary factors) from non-African Americans for the purpose of making direct comparisons for these parameters between the different racial groups to assess the contribution of non-genetic factors for susceptibility to the development of IBD. This study calls for recruiting AA patients and ethnically matched controls (friend or spouse). These persons will provide us with a blood sample and with information requested on a questionnaire asking the following: clinical course and history of their IBD or their general health, smoking history, socioeconomic variables and specific dietary factors known in some populations to be related to IBD etiology. Access to medical records will be used to confirm diagnoses. The clinical characteristics of IBD obtained from medical records will be summarized in a phenotyping form using a standardized NIDDK IBDGC Phenotyping Operations Manual. Controls will be asked health history to identify potentially unrecognized IBD. DNA and other biospecimens will be purified from blood. Samples and data will also be shared with the NIDDK IBDGC for use in IBDGC research projects and will be processed and maintained at NIDDK repositories.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

1. African Americans with a confirmed diagnosis of Inflammatory Bowel Disease (IBD)

2. African Americans without a diagnosis of IBD and without a family history of IBD for comparison purposes Exclusion Criteria: Patients whose IBD cannot be confirmed

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Weill Cornell Medical College	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Johns Hopkins University	Baylor College of Medicine, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Rutgers University, University of Alabama at Birmingham, University of Chicago

Country where clinical trial is conducted

United States,