NCT02394964

The Human Microbiome in Immune-Mediated Diseases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The immune system is influenced by the commensal microbes that live in the gut and on the skin. This study aims to characterize the microbiota of subjects with autoimmune disease in order to determine whether certain microbial species may cause or worsen immune-mediated diseases

Detailed description

This is a combination of a defined pilot microbiome study as well as exploratory mechanistic research with candidate commensals identified based on known structures accessible in public databases. In the observational prospective two-center study, subjects will be followed for 8 weeks. The study will consist of a total of 3 study visits (0, 4 and 8 weeks). Screening and baseline visits (week 0) will take place at the same time. A study window period of +/- 7 days will be allowed for follow-up study visits. The mechanistic in vitro research with subjects' blood cells and candidate commensals will typically require between 2-4 visits for sampling, but will not be limited by the frequency of visits.

Conditions

• Autoimmune

Interventions

Type	Name	Description
OTHER	Sample Collection	Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8

Timeline

• Start date: 2014-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2015-03-20
• Last updated: 2023-12-21

Locations

2 sites across 1 country: United States