Exercise and IBS-friendly diet program for people with fibromyalgia and IBS
Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study
This trial tests whether a combined exercise program and an IBS-friendly diet can reduce pain and gut symptoms in adults aged 30–65 who have both fibromyalgia and moderate-to-severe IBS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT06923800 on ClinicalTrials.gov |
What this trial studies
This randomized crossover trial recruits adults with both fibromyalgia and irritable bowel syndrome from outpatient clinics at IRCCS Saverio de Bellis in Italy. Participants will follow periods of a structured exercise program (including aerobic exercise) combined with an IBS-specific nutritional plan, with each participant receiving different interventions in separate phases. Outcome measures include symptom diaries, accelerometer monitoring of activity and sleep, blood/urine/stool sampling, and validated questionnaires on GI symptoms, fibromyalgia, psychological status, and quality of life. The crossover design lets each person serve as their own control to compare changes in pain, GI symptoms, sleep, and metabolic markers.
Who should consider this trial
Good fit: Adults 30–65 with confirmed fibromyalgia (ACR criteria) and Rome III/IV IBS with an IBS-SSS score ≥125, BMI 18.5–29.9, and no severe cardiac, hepatic, neurological, or psychiatric disorders.
Not a fit: People with severe comorbid illnesses, BMI outside 18.5–29.9, those unable to discontinue symptom-management medications, or those with only mild IBS are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the program could reduce pain, improve sleep and physical function, and lessen IBS symptoms, improving daily quality of life.
How similar studies have performed: Previous research shows exercise can help fibromyalgia and dietary strategies can reduce IBS symptoms, but combining a structured exercise program with an IBS-specific diet in a randomized crossover format is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Castellana Grotte, Bari
- IRCCS Saverio de Bellis — Castellana Grotte, Bari, Italy (Recruiting)
Study contacts
- Study coordinator: Antonella Bianco
- Email: antonella.bianco@irccsdebellis.it
- Phone: +390804994653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.