Exercise and IBS-friendly diet program for people with fibromyalgia and IBS
Official title: Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study
Run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · NCT06923800 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 65 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | September 2028 |
| Study ends | December 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06923800 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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) \> 175 (indicating moderate to severe IBS symptoms). * Men and women aged between 30 and 65 years. * Body Mass Index (BMI) between 18.5 and 34.9 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 it's running
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IRCCS Saverio de Bellis
Castellana Grotte, Bari, Italy Recruiting
Study contacts
- Study coordinator: Antonella Bianco
- Email: antonella.bianco@irccsdebellis.it
- Phone: +390804994653
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.