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Collection of Specimens for Study of Inflammatory Bowel Disease

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

This study will collect tissue specimens to be used for research on inflammatory bowel disease. The tissues will be used to explore why people get inflammatory bowel disease and to try to develop new treatments based on the study results. Tissue from patients with IBD will be compared with that from patients who do not have the disease

Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel disorder may be eligible for this study. Patients with IBD must be at least 4 years of age; those with another disorder must be 18 years of age or older.

Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed during the surgery that is not needed for medical care, such as for pathological examination, is provided to researchers for study under this protocol. In addition, patients with IBD provide a blood sample for genetic testing. Several genetic variations, or mutations, may increase the risk of developing IBD; blood samples from patients may help identify these variations.

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Natural History

Official Title: Procurement of Clinical Specimens for Immunologic or Genetic Studies in Inflammatory Bowel Diseases

Further Study Details: 

Expected Total Enrollment:  250

Study start: July 1, 2004

Our ongoing natural history studies of the etiology and immune abnormalities of the group of diseases known collectively as the inflammatory bowel diseases require access to clinical samples of intestinal tissue as well as blood samples for genotyping. This protocol provides a mechanism for procurement of intestinal samples obtained at the time of medically-indicated surgical procedures from patients with IBD or some other non-IBD diagnosis (to act as a control group). In addition it allows for the procurement of blood for DNA preparation as more IBD susceptibility genes are discovered and we further our work on association of genetic polymorphisms/mutations with the phenotype and immune abnormalities observed in our IBD patients.

Eligibility

Genders Eligible for Study:  Both

Criteria

SUBJECTS WITH INFLAMMATORY BOWEL DISEASE:
INCLUSION CRITERIA:
Presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings.
Ability to give consent or have legally authorized person give consent and agree to sample storage.
EXCLUSION CRITERIA:
Less than 4 years old.
SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE:
INCLUSION CRITERIA:
Absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses.
Ability to give consent and agree to sample storage.
EXCLUSION CRITERIA:
Less than 18 years of age.

Location and Contact Information


Maryland
      National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Study ID Numbers:  040231; 04-I-0231
Record last reviewed:  June 23, 2004
Last Updated:  June 23, 2004
Record first received:  July 2, 2004
ClinicalTrials.gov Identifier:  NCT00086554
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
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