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

RecruitingNAAges 18 Years - anyAllUniversitair Ziekenhuis Brussel
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ175 (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 (โ‰ฅ3 months) widespread pain(i.e., a Widespread Pain Index(WPI) score of โ‰ฅ7 with a Symptom Severity Score of โ‰ฅ5, or a WPI score of 4-6 with a Symptom Severity Score โ‰ฅ9 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 โ‰ค18 kg/mยฒ; or 7) have received osteopathic care for IBS and/or are already following the FODMAP dietary intervention.
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What it tests

  • Osteopathic care
  • Sham Osteopathic care
  • Flexi-FODMAP Diet
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Where

1 site
Vrije Universiteit Brussel
Brussels, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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