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

Last updated: October 17, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Colic

Treatment

N/A

Clinical Study ID

NCT01169194
NA_00041578
U01DK062431
  • Ages > 5
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 forcomparison purposes

Exclusion

Exclusion Criteria: Patients whose IBD cannot be confirmed

Study Design

Total Participants: 2400
Study Start date:
June 01, 2003
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

  • University of Maryland Baltimore/University of Maryland Medical System

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Meharry Medical College

    Nashville, Tennessee 37208
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390-9151
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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