Protocol Number: 82-I-0183

Title:

Studies of Immune Regulation in Patients with Ulcerative Colitis, Crohn's Disease, or Unclassified Inflammatory Bowel Diseases

Number:

82-I-0183

Summary:

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Subjects will meet the following criteria:

1. Individuals with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), i.e., abdominal pain, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms in which a diagnosis has not been verified.

or

2. Individuals with clinical features consistent with inflammatory bowel disease and histopathologic changes demonstrating inflammation of the intestine.

or

3. Individuals with a verifiable diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis or IBD known to be associated with co-existing conditions) which is supported by characteristic a) clinical features (symptomatic or endoscopic) or b) radiographic findings and c) histopathologic changes consistent with Crohn's disease or ulcerative colitis.

4. All subjects to be enrolled will be between ages 8-75.

5. To participate in the research biopsies during endoscopy, subjects must have the following lab values within two weeks of the procedure:

Hematocrit greater than 30%

Platelet count greater than 100,000

PT INR less than 1.3 or PTT prolonged by less than 3 seconds

EXCLUSION CRITERIA:

1. Failure to meet the 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.

Special Instructions: Currently Not Provided

Keywords:

Inflammatory Bowel Disease

Regional Enteritis

Crohn's Disease

Ulcerative Colitis

Recruitment Keywords:

Ulcerative Colitis

Inflammatory Bowel Disease

IBD

Conditions:

Crohn's Disease

Inflammatory Bowel Disease

Ulcerative Colitis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

The immunopathogenesis of gastrointestinal and hepatobiliary diseases

Increased interleukin-2 messenger RNA in the intestinal mucosal lesions of Crohn's disease but not ulcerative colitis

Antibodies to IL-12 abrogate established experimental colitis in mice

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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