Immune Regulation in Ulcerative Colitis or Crohn s Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001184|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : March 29, 2019
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:
- Blood drawing No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of blood per kilogram (2.2. pounds) of body weight will be obtained from children within the same time period, with no more than 3 ml/kg taken at any one time.
- Leukapheresis This procedure is done to collect large quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is circulated through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.
- Intestinal biopsies Intestinal tissue will be obtained during colonoscopy with intestinal biopsy in patients who require this procedure as part of their standard medical care. Patients are given a sedative to reduce anxiety, but are conscious during the procedure. A flexible tube is inserted into the rectum and large intestine, allowing the physician to see the intestinal mucosa. At various places, small pieces of tissue are plucked out.
|Condition or disease|
|Inflammatory Bowel Disease|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut|
|Study Start Date :||November 12, 1982|
- To identify the molecular abnormalities that result in inflammatory bowel diseases and develop novel therapies based on these discoveries. [ Time Frame: Ongoing ]
- To enroll patients with IBD in order to obtain clinical, therapeutic, immunological, and genetic data relevant to the research study of their disease. [ Time Frame: ongoing ]
- To enroll patients with complicated, known IBD, unclassified/suspected IBD, or in a group at risk for IBD, but as yet subclinical (as in certain genetic syndromes) to undergo conventional diagnostic as well as research procedures in order to cla... [ Time Frame: ongoing ]
- To assess patients with IBD for their suitability for experimental treatment protocols. [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001184
|Contact: Sandra M Maxwell, R.N.||(240) firstname.lastname@example.org|
|Contact: Ivan J Fuss, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Ivan J Fuss, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|