Actively Recruiting
A Natural History Study of Immune Regulation in Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Bowel Conditions
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
Researchers are studying how the immune system controls inflammation in the digestive tract in patients with Crohn's disease, ulcerative colitis, and other inflammatory bowel diseases. The study aims to identify molecular abnormalities that cause these diseases and to develop new treatments based on these findings. It includes patients from newborns up to 75 years old and collects clinical, therapeutic, immunological, and genetic data related to their condition. Participants will receive standard medical care for their condition, which may include anti-inflammatory drugs, immunosuppressants, antibiotics, and possibly surgery if needed. Procedures such as blood draws, leukapheresis to collect white blood cells, and intestinal biopsies during colonoscopy may be performed as part of their routine care or research purposes. Sedatives are used during biopsies to ensure comfort while patients remain conscious. During the study, participants undergo various tests including medical exams, blood and stool tests, X-rays, endoscopy, and biopsies to assess their disease. Researchers monitor immune function and inflammation through these procedures and collect samples to study molecular and cellular abnormalities. The study follows participants over time to gather detailed information to improve understanding and treatment of inflammatory bowel diseases.
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
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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.
I
Ivan J Fuss, M.D.
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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