Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

NCT ID: NCT01169207

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

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

Conditions

Inflammatory Bowel Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Unaffected

Individuals who do not have IBD

No interventions assigned to this group

Affected

Individuals with IBD

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florin Selaru, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00041583

Identifier Type: -

Identifier Source: org_study_id