Osteopathic care plus a flexible low‑FODMAP diet for people with fibromyalgia and IBS

Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial

This project will see if adding osteopathic care to a flexible low‑FODMAP diet helps adults with fibromyalgia who also have moderate-to-severe IBS.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitair Ziekenhuis Brussel (Academic / other)
• Locations: 1 site (Brussels, Brussels Capital)
• Trial ID: NCT07176078 on ClinicalTrials.gov

What this trial studies

This randomized, controlled trial enrolls adults with fibromyalgia and moderate-to-severe IBS to receive either real osteopathic care or sham osteopathic care while following a flexible FODMAP diet. Participants are randomized to the two hands-on treatments in addition to standardized dietary guidance, and outcomes are measured over the treatment period with follow-up at three months. The primary outcome is change in IBS symptom severity (IBS-SSS), and secondary outcomes include pain, quality of life, anxiety, fatigue, work productivity, gut microbiota composition, and safety/tolerability. The design aims to determine whether osteopathic manipulation provides additional benefit beyond the diet and usual care.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) diagnosed with IBS by Rome IV criteria with an IBS-SSS ≥175 and meeting 2016 criteria for fibromyalgia who can keep stable medications and attend in-person osteopathic sessions.

Not a fit: Patients with mild IBS (IBS-SSS <175), without fibromyalgia, with unstable medications or severe comorbidities, or who cannot attend in-person sessions or follow the diet are unlikely to benefit.

Why it matters

Potential benefit: If successful, combining osteopathic care with a flexible FODMAP diet could further reduce IBS symptoms and improve pain and quality of life for people with fibromyalgia.

How similar studies have performed: Previous small trials of manual and osteopathic therapies for IBS or fibromyalgia have shown mixed and modest benefits, so this combined approach remains exploratory.

Eligibility criteria

Inclusion Criteria:

This study includes participants who meet the following criteria:

1. are over 18 years old;
2. 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);
3. 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 Criteria:

This study excludes participants who meet any of the following criteria:

1. have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;
2. have diseases affecting gastrointestinal function, including a history of bariatric surgery;
3. have allergies or food hypersensitivity (other than lactose intolerance);
4. have any major dietary restrictions or food allergies;
5. are pregnant or planning pregnancy during the trial (within the next seven months);
6. have a BMI ≤18 kg/m²; or 7) have received osteopathic care for IBS and/or are already following the FODMAP dietary intervention.

Where this trial is running

Brussels, Brussels Capital

• Vrije Universiteit Brussel — Brussels, Brussels Capital, Belgium (Recruiting)

Study contacts

• Study coordinator: Evert Zinzen, PhD

Conditions Irritable Bowel Syndrome; Fibromyalgia; Osteopathic Care; FODMAP Diet