NCT01169207

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 1996Dec 2027

Study Start

First participant enrolled

July 1, 1996

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
17.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

31.4 years

First QC Date

July 23, 2010

Last Update Submit

January 15, 2026

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative ColitisIndeterminate ColitisIBDCDUCIC

Outcome Measures

Primary Outcomes (1)

  • Genetics of IBD

    Single visit, approximately 1 hour

Study Arms (2)

Unaffected

Individuals who do not have IBD

Affected

Individuals with IBD

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IBD patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals may contact by phone, mail or email after hearing about the study.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and derivative from blood, saliva

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Florin Selaru, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

July 1, 1996

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

US(1)