Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Recruiting now · Not applicable
Conditions studied: Fibromyalgia, Irritable Bowel Syndrome
In brief
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 between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.
Key facts
- Study ID
- NCT06923800
- Run by
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- People needed
- 30
- Starts
- 2025-04-14
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.
- Individuals unable to discontinue symptom management therapies and medications for FM/IBS.
Where it is running
- IRCCS Saverio de Bellis — Castellana Grotte, Bari, Italy (enrolling)
Full record on ClinicalTrials.gov
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