Status:
WITHDRAWN
Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chronic Granulomatous Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
3+ years
Brief Summary
Background: PIDD stands for primary immune dysregulation. It is a general term that includes many different inherited immune system disorders. The immune system is the part of the body that helps fig...
Detailed Description
Over 1 million people suffer from IBD in the United States. Although the exact pathogenesis is unclear, IBD results from an inappropriate inflammatory response to intestinal microbes which is influenc...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- General Inclusion Criteria - All individuals must meet the following criteria to be eligible for study participation:
- Age greater than or equal to 3 years.
- Willing to allow storage of samples for future research.
- Willing to allow genetic testing of their samples.
- Negative urine or serum pregnancy test for women of childbearing potential.
- Specific Inclusion Criteria for PIDD of Interest Cohort: Enrollment as a patient with confirmed PIDD or carrier status in a current NIH protocol, regardless of an IBD component.
- Specific Inclusion Criteria for IBD Cohort:
- Enrollment as a patient with confirmed IBD in a current NIH protocol.
- Absence of clinical findings or history suggestive of a primary or acquired immunodeficiency (not including immunodeficiency caused by certain IBD treatments).
- Specific Inclusion Criteria for non-PIDD/non-IBD Cohort (Healthy Volunteers):
- Absence of clinical findings or history suggestive of a primary or acquired immunodeficiency.
- Absence of clinical findings or history suggestive of IBD.
- EXCLUSION CRITERIA:
- General Exclusion Criteria - An individual who meets any of the following criteria will be excluded from study participation:
- Active malignancy requiring treatment.
- HIV.
- Current treatment for hepatitis B.
- Current treatment for hepatitis C.
- Recreational IV drug use within the past 6 months (based on subject report).
- Participation in a research study of an investigational vaccine within the past 6 months.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study.
- Specific Exclusion Criteria for PIDD of Interest Cohort: None.
- Specific Exclusion Criteria for IBD Cohort: None.
- Specific Exclusion Criteria for non-PIDD/non-IBD Cohort (Healthy Volunteers):
- Treatment with systemic antimicrobials within the past 3 months, unless it is a prophylactic regimen consisting of either an azole , trimethoprim-sulfamethoxazole, a quinolone, or any antimicrobial regimen resembling a typical prophylaxis regimen used to treat a PIDD of interest.
- Treatment with immune modulators within the past 6 months.
Exclusion
Key Trial Info
Start Date :
September 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03278912
Start Date
September 8 2023
End Date
September 8 2023
Last Update
September 13 2023
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892