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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Vrije Universiteit Brussel
  Brussels, Brussels Capital, Belgium Recruiting

Study contacts

• Study coordinator: Evert Zinzen, PhD
• Email: Evert.Zinzen@vub.be
• Phone: +32-2-629.27.17

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.