Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01169207
First received: July 23, 2010
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

This research is being done to find out why Inflammatory Bowel Disease (IBD) (i.e., Crohn's disease and ulcerative colitis) occurs in individuals and in families. Recently the investigators and other researchers have found a gene (DNA) that when changed, gives people a higher risk for developing IBD or other inflammatory diseases like IBD. By doing this research, scientists and doctors will study the cells in the blood to see how the gene-change affects the way the blood cells' immune system works.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 2500
Study Start Date: July 1996
Groups/Cohorts
Unaffected
Individuals who do not have IBD
Affected
Individuals with IBD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

IBD patient's are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals contact us by phone, mail or email after hearing about our study

Criteria

Inclusion Criteria:

ADULTS:

  • Patients with IBD and their family members who have or do not have IBD.
  • People that do not have IBD nor have a family member with IBD needed for comparison purposes.
  • The age inclusion criterion for the Multiple Blood Draw (MBD) is 18 years of age or older.

CHILDREN:

  • Children greater than age 4 with IBD and their family members who have or do not have IBD.
  • People that do not have IBD nor have a family member with IBD needed for comparison purposes.

Exclusion Criteria:

  • The only exclusions are age parameters and health reasons that would preclude their enrollment; such as, for anemic patients. Blood-draws on anemic patients may, in certain medical cases, pose a health risk to them; therefore, we request that if they are anemic that they present a letter from their personal physician giving explicit permission for them to join if at the time it is clinically advisable.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169207

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

Locations
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Patricia Ushry    888-279-4194    ibd@jhu.edu   
Contact: Denise Spears    (410) 502-5846    dspears@jhu.edu   
Principal Investigator: Steven R Brant, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Steven R Brant, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Steven R. Brant, M.D., Johns Hopkins University-School of Medicine
ClinicalTrials.gov Identifier: NCT01169207     History of Changes
Other Study ID Numbers: 96-01-31-06
Study First Received: July 23, 2010
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014