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 Combined Exercise Program + A specific nutritional plan for individuals with IBS, or Aerobic Exercise + A specific nutritional plan for individuals with IBS. The registry lists allocation as randomized. Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties.
They plan to enroll about 30 people at Castellana Grotte. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study
Interventions: Combined Exercise Program + A specific nutritional plan for individuals with IBS, Aerobic Exercise + A specific nutritional plan for individuals with IBS
Primary outcome (registry wording): Fibromyalgia symptom assesment