Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Inflammatory Bowel Disease Clinical Trial

Official title:

Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01169207
• Other study ID #: NA_00041583
• Status: Active, not recruiting
• Start date: July 1996
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

We initiated this research study in 1996 with the overall goal of identifying IBD susceptibility genes. In the beginning, our major focus was recruitment of multiply affected IBD pedigrees for linkage studies, but we have since expanded our study to include singleton cases and spousal/friend as well as population controls for comparison purposes Our 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

CHILDREN:

• Children age 5 or older with IBD and their 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 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States,