Immune Regulation in Ulcerative Colitis or Crohn s Disease
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||April 12, 2014|
|Start Date ICMJE||November 1982|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001184 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Immune Regulation in Ulcerative Colitis or Crohn s Disease|
|Official Title ICMJE||Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut|
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:
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. This study will also be used to provide a mechanism for procurement of intestinal samples obtained at sites outside the NIH at the time of medically indicated surgical or endoscopic procedures from patients with IBD. In addition, it will allow for the procurement (send-in) of blood for both immunological studies as well as 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. This protocol will also allow for the procurement of blood and tissue samples from healthy volunteers (without IBD) here at the NIH to use as a control group in comparison to the immunologic and genetic data we obtain from the IBD patients that are enrolled. 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
INCLUSION CRITERA FOR HEALTHY VOLUNTEERS:
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
|Ages||8 Years to 75 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001184|
|Other Study ID Numbers ICMJE||820183, 82-I-0183|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP