Institutional Review Board, Hospital for Special Surgery
June 26, 2013
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Cassyanne L. Aguiar,
Michael D. Lockshin, MD
This APS Microbiome study seeks to find if any particular intestinal bacteria may trigger antiphospholipid antibody (aPL) production. Collected data will include medical history, questionnaires, physical exams, blood, and stool tests. The study aims to recruit 40 participants. Participation will involve 3 study visits over a period of 2 months
- Group 1:Persistently Positive for Anti-β2-Glycoprotein-I Antibody
- Group 2: Negative for all aPL tests including Lupus Anticoagulant (LA)
test, Anticardiolipin Antibody (aCL) and aβ2GPI.
Selected Exclusion criteria:
- Another systemic autoimmune disease such as lupus
- History of gastrointestinal bleeding,
- Celiac disease or inflammatory bowel disease.