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Funding completed.
Sponsor study identifier
Secondary identifiers
observational
0
1 country
1
Study Start
September 8, 2023
Actual (reported)Primary Completion
September 8, 2023
Actual (reported)Study Completion
September 8, 2023
Actual (reported)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 fight disease and infection. People with PIDDs can develop many kinds of health problems. One of these is inflammatory bowel disease (IBD), which causes diarrhea and cramping. Researchers want to learn more about these disorders to develop possible treatments. Objective: To learn more about when and why IBD may develop in some people with PIDDs. Eligibility: People ages 3 and older who have PIDD or IBD. Healthy volunteers in this age group are also needed. Design: Visit 1: Participants will be screened with physical exam, medical history, and blood and urine tests. Visit 2: Participants will:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 8, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2017
Actual (reported)September 12, 2017
Actual (reported)September 8, 2023
Actual (reported)September 8, 2023
Actual (reported)September 8, 2023
Actual (reported)Disease-specific intestinal microbiome signatures, and related localized and systemic immune responses.
1\. Microbiome, metabolomics, and transcriptomic signatures will be examined between comparison groups.
Baseline and Annual follow-up visits spanning 10 years
Changes in microbiome signatures. Changes in metabolomic and transcriptomic signatures.
Baseline and Annual follow-up visits spanning 10 years
Changes in systemic and tissue-specific markers of innate and adaptive immunity.
Baseline and Annual follow-up visits spanning 10 years
Disease-specific differences in relative quantity and function of peripheral blood and tissue immune cells (includes hematopoietic and stromal cells).
Throughout length of study
-Patients with IBD without a diagnosed PIDD.-First- or second-degree relatives of patients with a PIDD of interest who do not have a PIDD themselves, but have diagnosed or suspected IBD.
healthy volunteers
CGD cohort; IPEX syndrome cohort; CTLA4 haploinsufficiency cohort; LRBA deficiency and hypomorphic RAG deficiency cohorts
The study population will include patients and healthy volunteers greater than or equal to 3 years of age; PIDDs of interest, IBD, and Non-PIDD/non-IBD (healthy volunteers)@@@@@@
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Agarwal S, Mayer L. Gastrointestinal manifestations in primary immune disorders. Inflamm Bowel Dis. 2010 Apr;16(4):703-11. doi: 10.1002/ibd.21040.
Marciano BE, Rosenzweig SD, Kleiner DE, Anderson VL, Darnell DN, Anaya-O'Brien S, Hilligoss DM, Malech HL, Gallin JI, Holland SM. Gastrointestinal involvement in chronic granulomatous disease. Pediatrics. 2004 Aug;114(2):462-8. doi: 10.1542/peds.114.2.462.
Christa S Zerbe, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
0 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2017
First Posted
September 12, 2017
Study Start
September 8, 2023
Actual (reported)Contact the study team to confirm eligibility.
Uhlig HH. Monogenic diseases associated with intestinal inflammation: implications for the understanding of inflammatory bowel disease. Gut. 2013 Dec;62(12):1795-805. doi: 10.1136/gutjnl-2012-303956.
Primary Completion
September 8, 2023
Actual (reported)Study Completion
September 8, 2023
Actual (reported)Last Updated
September 13, 2023
Record last verified: 2023-09
.The following will be shared:@@@@@@ (Summation)De-identified data in an NIH-funded or approved public repository.@@@@@@ (Summation)Identified data in the Biomedical Translational Research Information System (BTRIS).@@@@@@.De-identified or identified data with approved NIH-based and/or outside collaborators under appropriate agreements.
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Source: ClinicalTrials.gov.
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