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NCT00001184 · ClinicalTrials.gov registry record
Immune Regulation in Ulcerative Colitis or Crohn s Disease
A clinical trial of Ulcerative Colitis and Inflammatory Bowel Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT00001184 is a study of Ulcerative Colitis and Inflammatory Bowel Disease that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,000 participants, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001184, a study of Ulcerative Colitis and Inflammatory Bowel Disease, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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 0 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 th
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 1998-08-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001184
The ClinicalTrials.gov registry entry for NCT00001184 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (51% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 0 interventions.
NCT00001184 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001184 about?
NCT00001184 is a clinical study titled "Immune Regulation in Ulcerative Colitis or Crohn s Disease". 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 d...
What is the current status of trial NCT00001184?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 1998-08-07.
What conditions does trial NCT00001184 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Inflammatory Bowel Disease, Chrohn's Disease.
Who is sponsoring clinical trial NCT00001184?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001184 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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