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

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. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care. The main questions it aims to answer are: Does osteopathic care reduce IBS symptom severity more than sham osteopathic care? Does osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care? Do participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention? Can pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care? What adverse effects occur with osteopathic care compared to sham care? Participants will: Visit the osteopathy clinic to receive four sessions of real or sham osteopathic care Complete online assessments before and after the intervention, and at 3- and 6-months post-intervention Provide stool samples before and after the four osteopathic or sham sessions Keep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention

NCT Number	NCT07176078
Lead Sponsor	Universitair Ziekenhuis Brussel
Conditions	Irritable Bowel Syndrome (IBS), Fibromyalgia (FM)
Enrollment	96 participants
Start Date	2026-01-01
Primary Completion	2026-12 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-17