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Active, Not Recruiting

NCT Number: NCT01169207

Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This current protocol was established in 1996 with the goal of identifying the genetic and environmental components that contribute to the development of IBD, especially in families.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

About this study

The investigators initiated this research study in 1996 with the overall goal of identifying IBD susceptibility genes. In the beginning, the major focus was recruitment of multiply affected IBD pedigrees for linkage studies, but the investigators have since expanded the study to include singleton cases and spousal/friend as well as population controls for comparison purposes The investigator's recruitment goal is 2500 subjects.

Blood samples obtained from participants are used to isolate lymphocytes for storage, serum for serological analysis of antibodies and other proteins relevant to IBD and DNA for genotyping or sequencing. Lymphocytes may be transformed with EBV to establish immortalized lymphoblastoid cell lines. These cell lines can be used as a secondary DNA source or to study IBD relevant gene, protein expression and cell function

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ADULTS:

  • Patients with IBD and 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.

CHILDREN:

  • Children age 5 or older with IBD and family members who have or do not have IBD.
  • Children 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 enrollment; such as, for anemic patients. Blood-draws on anemic patients may, in certain medical cases, pose a health risk; therefore, the investigators request that if the participants are anemic that the participants present a letter from the participant's personal physician giving explicit permission for the participant to join if at the time it is clinically advisable.

Treatment and study plan

Primary outcomes

  1. Genetics of IBD

    Time frame: Single visit, approximately 1 hour

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
1996
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2010
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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