Search / Trial NCT00001184

Immune Regulation in Ulcerative Colitis or Crohn s Disease

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

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Trial Information

Current as of December 26, 2024

Recruiting

Keywords

Cgd Related Ibd Ibd Hermansky Pudlak Syndrom Natural History

ClinConnect Summary

This clinical trial is looking into how the immune system manages inflammation in patients with Crohn's disease and ulcerative colitis, which are types of inflammatory bowel disease. Researchers want to understand the role of certain white blood cells, called lymphocytes, in causing inflammation in the stomach and intestines. The study will not involve any new treatments but will follow standard care practices for managing these conditions.

To participate, patients aged 0 to 75 with Crohn's disease, ulcerative colitis, or related symptoms may be eligible. Participants will undergo routine medical tests, including blood tests and possibly procedures like colonoscopies, to help gather information about their condition. While receiving standard medical treatment, they might also have blood drawn and, in some cases, white blood cells collected for research. It's important to note that this study aims to better understand these diseases and improve future treatments, and patients will be closely monitored throughout the process.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • • 1. Patients with a verifiable diagnosis of Crohn s disease, ulcerative colitis, or IBD known to be associated with a co-existing condition and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal
  • • changes OR
  • • 2. Patients with clinical features consistent with an unclassified inflammatory bowel disease and histologic evidence of inflammation of the intestine OR
  • • 3. Patients with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), including but not limited to abdominal pain, fistulae, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms (pyoderma, erythema
  • • nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified. OR
  • • 4. Patients who have a defined genetic syndrome linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD
  • • 5. All subjects to be enrolled will be between ages 0-75 (Participants coming to the NIH Clinical Center must meet age and weight requirements of the clinical center, but \> 18 must years old for patients without IBD and may be as young as 0-2 years old for mail-in
  • • samples).
  • 6. To participate in the research biopsies during endoscopy, subjects must have the following lab values within two weeks of the procedure:
  • • Hematocrit greater than or equal to 30%
  • • Platelet count greater than 100,000
  • • PT INR less than or equal to 1.3 or PTT prolonged by less than or equal to 3 seconds
  • • 7. Ability to consent to the protocol on their own.
  • INCLUSION CRITERIA 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 greater than or equal to 18 years old.
  • • 3. Must be willing to submit samples for storage.
  • INCLUSION OF EMPLOYEES IN THE NIH INTRAMURAL STUDIES:
  • • NIH employees and members of their immediate families may participate in this protocol. We will follow the Guidelines for the Inclusion of Employees in NIH Research Studies and will give each employee a copy of the NIH information sheet on Employee Research Participation.
  • For NIH employees:
  • • 1. Neither participation nor refusal to participate will have an effect, either beneficial or adverse, on the participant s employment or work situation.
  • • 2. The NIH information sheet regarding NIH employee research participation will be distributed to all potential subjects who are NIH employees.
  • • 3. The employee subject s privacy and confidentiality will be preserved in accordance with NIH Clinical Center and NIAID policies, which define the scope and limitations of the protections.
  • • 4. For NIH employee subjects, consent will be obtained by an individual independent of the employee s team. Those in a supervisory position to any employee and co-workers of the employee will not obtain consent. The protocol study staff will be trained annually on obtaining potentially sensitive and private information from co-workers or subordinates. This training will be reinforced as needed, at weekly team meetings.
  • 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.
  • 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.

Trial Officials

Ivan J Fuss, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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