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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01169194
Recruitment Status : Recruiting
First Posted : July 26, 2010
Last Update Posted : November 1, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Rutgers University
University of Alabama at Birmingham
University of Chicago
University of Louisville
University of Maryland, Baltimore
University of North Carolina, Chapel Hill
Weill Medical College of Cornell University
Meharry Medical College
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease
Inflammatory Bowel Disease

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)
Actual Study Start Date : June 2003
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Affected
Patients with IBD
Unaffected
Individuals who do not have IBD


Outcome Measures
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Biospecimen Retention:   Samples With DNA
whole blood and derivatives from blood, saliva

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with Inflammatory Bowel Disease
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169194


Contacts
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Contact: Lisa Datta, MS 410-502-0040 ibd@jhu.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Angelia Johnson    205-934-0498    angeliagjohnson@uabmc.edu   
Principal Investigator: Kirk Russ, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kristi Kearney, RN    773-834-7414    kkearney@medicine.bsd.uchicago.edu   
Principal Investigator: Joel Pekow, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susie Mann, LPN    502-852-1919    suzanne.mann@louisville.edu   
Principal Investigator: Gerald Dryden, MD         
United States, Maryland
University of Maryland Baltimore/University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Howard Kader, MD         
Principal Investigator: Howard Kader, MD         
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Lisa Datta, MS    410-502-0040    ibd@jhu.edu   
Principal Investigator: Mark Lazarev, MD         
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact    732-235-3241    IBD_genetics@rwjms.rutgers.edu   
Principal Investigator: Steven R Brant, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Fatiha Chabouni    212-746-5109    fac2005@med.cornell.edu   
Principal Investigator: Ellen Scherl, MD         
United States, North Carolina
University of North Carolina Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Jackson, MPA    919-843-9071    Susan_jackson@med.unc.edu   
Principal Investigator: Edward Barnes, MD         
United States, Tennessee
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
Contact: Carol Galvez         
Principal Investigator: Duane Smoot, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Genesis Vidales, MBBS    713-798-7616    Genesis.VidalesLopez@bcm.edu   
Principal Investigator: Jason K Hou, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Rutgers University
University of Alabama at Birmingham
University of Chicago
University of Louisville
University of Maryland, Baltimore
University of North Carolina, Chapel Hill
Weill Medical College of Cornell University
Meharry Medical College
Investigators
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Principal Investigator: Mark Lazarev, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01169194    
Other Study ID Numbers: NA_00041578
U01DK062431 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
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
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis