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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

RecruitingNAAges 30 Years - 65 YearsAllAzienda Ospedaliera Specializzata in Gastroentero…
NCT06923800 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting bet

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📋 Eligibility rules (as published)
Inclusion Criteria: * Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III/IV diagnostic criteria for IBS. * Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) ≥ 125 (indicating moderate to severe IBS symptoms). * Men and women aged between 30 and 65 years. * Body Mass Index (BMI) between 18.5 and 29.9. Exclusion Criteria: * Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases. * Individuals unable to discontinue symptom management therapies and medications for FM/IBS.
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What it tests

  • Combined Exercise Program + A specific nutritional plan for individuals with IBS
  • Aerobic Exercise + A specific nutritional plan for individuals with IBS
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Where

1 site
IRCCS Saverio de Bellis
Castellana Grotte, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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