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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001184 |
This study will investigate in patients with Crohn's disease and ulcerative colitis how the body's immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments.
Patients between the ages of 8 and 75 years of age with Crohn's disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may include the following: medical history and physical examination, routine blood tests, examination of stool specimens, X-rays such as barium enema or upper GI series, proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.
Participants will receive medical treatment according to the best generally accepted measures for treating Crohn's disease or ulcerative colitis. This may include anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be recommended for patients whose disease does not respond to medical treatment. If surgery to remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform the procedure.
In addition, participants may undergo the following procedures:
Condition |
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Crohn's Disease Inflammatory Bowel Disease Ulcerative Colitis |
Study Type: | Observational |
Official Title: | Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut |
Estimated Enrollment: | 1000 |
Study Start Date: | November 1982 |
This natural history protocol provides for the evaluation of patients with idiopathic inflammatory bowel disease (ulcerative colitis, Crohn's disease, IBD associated with immunodeficiency and genetic diseases, such as chronic granulomatous disease and Hermansky-pudlak syndrome, and additional undefined inflammatory conditions of the gut) either on an inpatient or outpatient basis. The purpose of this protocol is to assess the extent and activity of the disease in such patients, conduct immunologic studies of lymphocyte and antigen-presenting cells derived from peripheral blood and tissues, administer and monitor treatments, and study the genetic risk factors for these diseases. The immediate aims of these studies are to define the immunologic abnormalities present and to identify genetic susceptibility factors in patients with these diseases. The long term goal of this protocol is to identify specific targets for development of novel therapeutics for inflammatory bowel diseases.
Ages Eligible for Study: | 8 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients with verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition and which is supported by characteristic features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes;
OR
Patients with clinical features consistent with an unclassified bowel disease and histologic evidence of inflammation of the intestine;
OR
Patients with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), including but not limited to abdominal pain, fistulae, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms (pyoderma, erythema nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified;
OR
Hematocrit greater than or equal to 30%
Platelet count greater than 100,000
PT INR less than or equal to 1.3 or PTT prolonged by less than 3 seconds
EXCLUSION CRITERIA:
NOTE: Pregnant patients are not excluded from enrolling in this natural history protocol, but they are excluded from research procedures such as pheresis, more than 100 ml venipuncture volumes within 6 weeks, and research endoscopies. However, they are eligible for and tests or procedures that are medically-indicated and can be done with minimal risk to the fetus.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 820183, 82-I-0183 |
Study First Received: | November 3, 1999 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00001184 |
Health Authority: | United States: Federal Government |
Inflammatory Bowel Disease Regional Enteritis Crohn's Disease Ulcerative Colitis |
Ulcerative Colitis Inflammatory Bowel Disease IBD |
Digestive System Diseases Gastrointestinal Diseases Ulcer Enteritis Colonic Diseases Crohn Disease |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
Pathologic Processes |