Immune Regulation in Ulcerative Colitis or Crohn s Disease

Conditions Phase Intervention Type
N/A

Eligibility

Ages Eligible for Study
8 years to 75 years
Genders Eligible for Study
Both

Keywords

Inflammatory Bowel Disease, Regional Enteritis, Crohns Disease, Ulcerative Colitis, and IBD

Sponsors

NIH
National Institute of Allergy and Infectious Diseases (NIAID)

Inclusion Criteria

2. Any medical, psychiatric, or social conditions which, in the opinion of the
investigators, would make participation in this protocol not in the best interest of
the subject.

NOTE: Pregnant patients are not excluded from enrolling in the IBD natural history
protocol, but they are excluded from research procedures such as pheresis, more than 100 ml
venipuncture volumes within 8 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:

1. Must be willing to undergo blood draw and/or upper endoscopy and colonoscopy with
biopsy to obtain material for research purposes.

2. Must be > 18 years old.

3. Must be willing to submit samples for storage.

Exclusion Criteria

FOR HEALTHY VOLUNTEERS:

1. History of inflammatory bowel disease.

2. Acute systemic or intestinal infection requiring antibiotics

3. Any condition that, in the investigator s opinion, places the patient at undue risk by
participating in the study

Detailed Description

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001184

Overall Contact

Ivan J Fuss, M.D.
(301) 496-9663

Overall Contact Backup

Sandra M Maxwell, R.N.
(240) 627-3078

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland United States

    Status: Recruiting

    Contact info For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
    800-411-1222xTTY8664111010