Gene Expression in Inflammatory Bowel Disease

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:
NCT01171872
First received: July 28, 2010
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

The causes of inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are unknown and diagnosing them is often difficult. This research is being done to find the genes that may increase the risk of inflammatory bowel disease, and to identify specific protein substances that are related to IBD. The investigators are also looking at cell factors that may predict response to treatment for IBD. In IBD, cells of the gastrointestinal tract (your gut) do not seem to respond to certain substances in a normal way. Scientist have discovered that the immune system, made up of cells and chemicals that defend your body from infections, is working in a way that damages the walls of the gut. You are being asked to join in this study because you are going to have an surgical procedure performed related to your diagnosis of Crohn's disease or ulcerative colitis or for other medical reasons (for comparison purposes). If you join this study, the investigators will study the cells in the resected tissue from your gut to find out why some cells do not act in the normal way in people with IBD as compared to people without IBD. The more the investigators understand about how differently these cells are working, the better doctors and scientists will be able to someday help people with IBD.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Gene Expression in Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Biospecimen Retention:   Samples With DNA

whole blood, serum, tissue


Estimated Enrollment: 600
Study Start Date: November 1999
Groups/Cohorts
Unaffected
Individuals who do not have IBD
Affected
Individuals who have IBD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals who are to undergo upper or lower gastrointestinal endoscopies or a surgical resection as part of their normal medical care and deemed necessary by their physicians.

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:

  • All persons, regardless of IBD affection status, greater than 7 years of age undergoing upper or lower endoscopy or bowel resection with an emphasis on targeting patients diagnosed with C.difficile as a specific control group for comparison.

Exclusion Criteria:

  • Persons with bleeding tendencies
  • Persons on anti-coagulation therapy or who will be place on anti-coagulation therapy following the planned endoscopy procedures
  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: NCT01171872

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 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.         
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: NCT01171872     History of Changes
Other Study ID Numbers: 99-09-09-07
Study First Received: July 28, 2010
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014