June 26, 2013
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Cassyanne L. Aguiar,
Michael D. Lockshin, MD
Odelya Pagovich
Martin Kriegel
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
Inclusion criteria:
- Group 1:Persistently Positive for Anti-β2-Glycoprotein-I Antibody
(aβ2GPI).
- 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.
CassyanneAguiar
aguiarc@hss.edu,
212.606.1151