Gene Expression in Inflammatory Bowel Disease

NCT01171872 | Enrolling By Invitation DMC

• 4 other identifiers: NA_00038329U01DK062431R24DK099803P01AI125181
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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 protocol is aimed at obtaining tissue samples to test for expression of genes associated with IBD and to better understand the pathogenesis of IBD with the study of genetics, proteomics, physiologic processes and microbiomes (microbiology).

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease; Inflammatory Bowel Disease (IBD); Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis; IBD; CD; UC; IC

Outcome Measures

Primary Outcomes (1)

• Gene Expression in IBD

  Single visit, approximately 1 hour

Study Arms (2)

Unaffected

Individuals who do not have IBD

Affected

Individuals who have IBD

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are to undergo upper or lower gastrointestinal endoscopies or a surgical resection as part of their normal medical care and deemed necessary by their physicians. Patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals can contact us by phone, mail or email after hearing about our study.

You may qualify if:

• All persons, regardless of IBD affection status, greater than 7 years of age undergoing upper or lower endoscopy or bowel resection

You may not qualify if:

• Persons with bleeding tendencies
• Persons on anti-coagulation therapy or who will be place on anti-coagulation therapy following the planned endoscopy procedures

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, tissue

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic 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 28, 2010
• First Posted: July 29, 2010
• Study Start: November 1, 1999
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)