Status:
NOT_YET_RECRUITING
Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Irritable Bowel Syndrome (IBS)
Fibromyalgia (FM)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms...
Eligibility Criteria
Inclusion
- This study includes participants who meet the following criteria:
- are over 18 years old;
- have a diagnosis of IBS by a medical doctor according to the Rome IV criteria and have an IBS-SSS score of ≥175 (indicating moderate to severe IBS symptoms);
- have a medical diagnosis of fibromyalgia or meet the 2016 American College of Rheumatology criteria, characterized by chronic (≥3 months) widespread pain(i.e., a Widespread Pain Index(WPI) score of ≥7 with a Symptom Severity Score of ≥5, or a WPI score of 4-6 with a Symptom Severity Score ≥9 on the Widespread Pain Index).
- Participants will be allowed to use probiotic products and follow a lactose-reduced diet, as long as they kept their usual intake throughout the study, unless a further reduction in lactose was recommended for those assigned to diet therapy. IBS medications, including antidepressants, will be allowed if used consistently at a stable dose for at least 2-3month prior to inclusion. Additionally, participants will need to be willing to adjust their current dietary habits in order to take part in the study.
Exclusion
- This study excludes participants who meet any of the following criteria:
- have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;
- have diseases affecting gastrointestinal function, including a history of bariatric surgery;
- have allergies or food hypersensitivity (other than lactose intolerance);
- have any major dietary restrictions or food allergies;
- are pregnant or planning pregnancy during the trial (within the next seven months);
- have a BMI ≤18 kg/m²; or 7) have received osteopathic care for IBS and/or are already following the FODMAP dietary intervention.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07176078
Start Date
October 1 2025
End Date
June 1 2027
Last Update
September 16 2025
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