We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS): The Search for New Genes (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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01169194
Recruitment Status : Unknown
Verified July 2011 by Johns Hopkins University.
Recruitment status was:  Recruiting
First Posted : July 26, 2010
Last Update Posted : July 8, 2011
Information provided by:

Study Description
Brief Summary:

The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population. Who May Join This Study? Blacks / African Americans with or without Crohn's disease or ulcerative colitis.

If you agree to join the study, the investigators ask that you give us 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

  Show Detailed Description

Study Design

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)
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Patients with IBD and their family members who have or do not have IBD.
Individuals who do not have IBD

Outcome Measures

Biospecimen Retention:   Samples With DNA

Blood samples from each participant will be sent to the NIDDK repository for DNA purification, sample distribution, establishment of cell lines. Serum samples will be sent to Fisher Bioservices Repository.

All additional samples will be processed and stored at Dr. Brant's Johns Hopkins IBD Genetics Laboratory with isolated lymphocytes and cell cultures made and stored at the Johns Hopkins Cell Center with use restricted to the PI (Dr. Brant).

Eligibility Criteria

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.

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient's of gastroenterology departments at medical centers.

Inclusion Criteria:

  • Patients with IBD and their family members who have or do not have IBD.
  • People that do not have IBD are needed for comparison purposes.

Exclusion Criteria:

  • Patients whose IBD diagnosis can not be confirmed with medical records.
Contacts and Locations

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

Contact: Patricia Ushry 1(888) 279-4194 ibd@jhu.edu
Contact: Denise Spears, BA (410) 502-5846 dspears1@jhmi.edu

United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Michelle Mendoza, MD, CCRC    202-877-6181    michelle.mendoza@medstar.net   
Sub-Investigator: Averell Sherker         
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Contact: Melvin Hall    202-865-4688    m_l_hall@howard.edu   
Principal Investigator: Duane Smoot, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Amy Gunnett, RN    352-265-0680 ext 40185    amy.gunnett@medicine.ufl.edu   
Principal Investigator: John Valentine, M. D.         
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Patricia Ushry    888-279-4194    ibd@jhu.edu   
Contact: Denise Spears, BA    (410) 502-5846    dspears@jhu.edu   
Principal Investigator: Steven R Brant, M.D.         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Samuels, CCRP    248-344-2358    qsamuel1@hfhs.org   
Contact: Sara Mukhashen, MSA    (313) 916-6049    smukhas1@hfhs.org   
Principal Investigator: Ann Silverman, M.D.         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7032
Contact: Mikki Sandridge    919-843-3873    mikki_sandridge@med.unc.edu   
Contact: Dolly Walkup    (919) 843-8105    dolly_walkup@med.unc.edu   
Principal Investigator: Kim Isaacs, M.D., Phd         
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
Howard University
Washington Hospital Center
University of North Carolina
University of Florida
Henry Ford Hospital
Baylor College of Medicine
Columbia University
Weill Medical College of Cornell University
University of Maryland
Principal Investigator: Steven R Brant, M.D. Johns Hopkins University
More Information

Responsible Party: Steven R. Brant, M.D., Johns Hopkins University-School of Medicine
ClinicalTrials.gov Identifier: NCT01169194     History of Changes
Other Study ID Numbers: 03-09-11-09
1U01DK062431 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2011

Keywords provided by Johns Hopkins University:
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
African American IBD
African American CD
African American UC
Black IBD
Black CD
Black UC
African American Inflammatory Bowel Disease
African American Crohn's Disease
African American Ulcerative Colitis
Black Inflammatory Bowel Disease
Black Crohn's Disease
Black Ulcerative Colitis

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases