Study of Osteopathic Care Combined With a Flexible FODMAP Diet for Adults With Fibromyalgia and Irritable Bowel Syndrome

What this Trial Is About

Researchers are studying adults with irritable bowel syndrome IBS and fibromyalgia to see if adding osteopathic care to a flexible FODMAP diet improves IBS symptoms. The trial aims to find out if real osteopathic care reduces symptom severity and other issues like pain, quality of life, anxiety, fatigue, and work productivity better than sham care. It will also look at diet adherence, safety, and whether effects last up to six months after treatment, while exploring whether personal factors can predict response to osteopathic care. Participants will be randomly assigned to receive either four weekly sessions of personalized osteopathic care or sham osteopathic care, both combined with a 4-week online flexi-FODMAP diet program. Osteopathic care includes a medical history, examination, treatment, and advice tailored by an osteopath using various manual techniques. Sham care mimics examination and light touch without therapeutic intent. The diet is a less restrictive version of the FODMAP elimination diet, delivered through a customized online platform. During the study, participants will visit the clinic for four treatment sessions and complete online assessments before and after intervention, as well as at 3 and 6 months follow-up. They will provide stool samples and keep food and stool diaries at these times. Researchers will measure changes in IBS symptom severity, pain, fatigue, quality of life, anxiety, depression, sleep quality, stress, work productivity, gut microbiota, diet adherence, and patient satisfaction. The study will monitor safety and tolerability of osteopathic care throughout the trial period.

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