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Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations

NCT03278912 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-09-13

No results posted yet for this study

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 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:

* Have more physical exams and blood and urine tests.
* Answer questions about quality of life and food history.
* Provide a stool sample.
* Have nasal and rectal skin swabs.
* Have saliva collected.

Participants will have 1 follow-up visit per year. They will repeat visit 2 procedures.

Participants will be contacted by phone or email in between yearly visits. They will be asked about their health. They will complete a quality-of-life questionnaire and send a stool sample that is collected at home.

If participants experience a sudden change in symptoms or undergo a new treatment, they may be asked to complete visit 2 procedures.

If participants are not able to come to NIH, study data and samples can be collected without an in-person visit.

Participants will have a final study visit about 10 years after Visit 1. They will repeat visit 2 procedures.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Christa S Zerbe, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2023-09-08
Completion
2023-09-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278912 on ClinicalTrials.gov