What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Synbiotic Supplement, or Placebo. The registry lists allocation as randomized. This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity.
They plan to enroll about 32 people at Istanbul. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome
Interventions: Synbiotic Supplement, Placebo
Primary outcome (registry wording): Change in body weight