Clinical trial NCT01169207: Johns Hopkins Crohn's Disease and Ulcerative Colitis Study
Official title: Johns Hopkins Crohn's Disease and Ulcerative Colitis Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
IBD
CD
UC
IC
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals may contact us by phone, mail or email after hearing about our study

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: 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

Eligibility 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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Florin Selaru, M.D.
role: PRINCIPAL_INVESTIGATOR
References: