Actively Recruiting
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-07
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed Crohn's disease, ulcerative colitis, or related inflammatory bowel disease supported by clinical, radiographic, endoscopic, or histologic findings
- Patients with clinical features and intestinal inflammation consistent with unclassified inflammatory bowel disease
- Patients showing symptoms suggestive of inflammatory bowel disease such as abdominal pain, fistulae, weight loss, diarrhea, blood in stool, or related extra-intestinal symptoms
- Patients with a genetic syndrome linked to inflammatory bowel disease risk, with or without symptoms
- Participants must be between 0 and 75 years old
- For research biopsies during endoscopy, certain blood lab values must be met within two weeks prior: hematocrit > 30%, platelet count > 100,000, PT INR < 1.3 or PTT prolonged by < 3 seconds
- Ability to consent to the protocol independently
- Healthy volunteers must be at least 18 years old and willing to undergo blood draws and/or endoscopy with biopsy and submit samples for storage
- NIH employees and their immediate families may participate under specific guidelines
You will not qualify if you...
- Failure to meet inclusion criteria
- Any medical, psychiatric, or social condition that would make participation not in the subject's best interest
- For healthy volunteers: history of inflammatory bowel disease
- For healthy volunteers: acute systemic or intestinal infection requiring antibiotics
- Any condition placing the patient at undue risk as judged by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sandra M Maxwell, R.N.
CONTACT
I
Ivan J Fuss, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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