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Pilot Study of Gut Commensals in Antiphospholipid Syndrome

NCT01787305 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2025-08-13

No results posted yet for this study

Summary

The purpose of this study is to explore if certain commensals within the gut microbiota (the collection of all microbes that live inside the gut) correlate with autoantibodies in the autoimmune clotting disorder called antiphospholipid syndrome. The study hypothesis is that particular commensals induce the autoantibodies (immune molecules that bind to self structures) and thus correlate with the level of immune cells and antibodies that are self-reactive. Participants are patients with antiphospholipid syndrome and individuals who have tested positive on a prior blood test for anti-beta2-glycoprotein I antibodies or those that have tested negative for antiphospholipid antibodies in their blood, but had a clotting event or a health problem that puts them at risk to form blood clots.

Conditions

  • Antiphospholipid Syndrome (APS)

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Martin A Kriegel, MD PhD · Yale University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-01-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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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 NCT01787305 on ClinicalTrials.gov