Clinical trial NCT01169194: Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)
Official title: Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
IBD
CD
UC
IC
African American IBD
African American CD
African American UC
African American IC
Black IBD
Black CD
Black UC
Black IC
African American Inflammatory Bowel Disease
African American Crohn's Disease
African American Ulcerative Colitis
African American Indeterminate Colitis
Black Inflammatory Bowel Disease
Black Crohn's Disease
Black Ulcerative Colitis
Black Indeterminate Colitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-07-26
Enrollment: 2400
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with Inflammatory Bowel Disease

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mark Lazarev, MD
role: PRINCIPAL_INVESTIGATOR
References: