Status:
RECRUITING
Exercise, Irritable Bowel Syndrome and Fibromyalgia
Lead Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Conditions:
Fibromyalgia
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The project focuses on "somatic functional syndrome", a category of disorders characterized by subjective symptoms, suffering and disability without evident organic or functional alterations. Syndrome...
Detailed Description
Patient Recruitment: the study protocol has been designed as a prospective, single-center, active-agent-controlled comparison in parallel groups of adult outpatients (18-65 years) affected by: 1. fib...
Eligibility Criteria
Inclusion
- Satisfaction of the ACR diagnostic criteria for the diagnosis of FM,
- A total Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) score of ≥ 125 (moderate to severe IBS symptoms) for the satisfaction of the Rome III-IV criteria in patients with IBS.
Exclusion
- Serious cardiac, hepatic, neurological, psychiatric, or gastrointestinal diseases other than IBS (e.g., inflammatory bowel disease, diverticular disease/diverticulitis) that could explain the current symptoms.
- Specific therapy for symptoms due to pathologies (educational programs, alternative medicine, psychotherapy). In the case of subjects who were previously undergoing treatment, they may participate in the study provided they suspend the ongoing therapy until the symptoms reappear.
- The use of drugs to treat FM and IBS.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06166563
Start Date
September 4 2023
End Date
December 1 2025
Last Update
May 1 2025
Active Locations (1)
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1
IRCCS Saverio de Bellis
Castellana Grotte, Bari, Italy, 70013