Status:
NOT_YET_RECRUITING
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Lead Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions:
Fibromyalgia
Irritable Bowel Syndrome
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscl...
Detailed Description
Patient Recruitment: The study is designed as a randomized crossover trial. Patients will be recruited from the "Rheumatology," "Pain Therapy," and "Celiac Disease and Functional Disorders" adult (30-...
Eligibility Criteria
Inclusion
- 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
- Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.
- Individuals unable to discontinue symptom management therapies and medications for FM/IBS.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06923800
Start Date
April 1 2025
End Date
December 1 2028
Last Update
April 27 2025
Active Locations (1)
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1
IRCCS Saverio de Bellis
Castellana Grotte, Bari, Italy, 70013