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

Официальное название

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

Обзор

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

Вмешательства

• Другое Osteopathic care
  Participants allocated to the osteopathic care group will receive 4 weekly consultations of person-centered osteopathic care. Each consultation will last approximately 45 minutes and consist of a careful medical history, a clinical examination, treatment, and advice (e.g. exercise, dietary, lifestyle). The osteopathic treatment protocol could be labeled as 'custom tailored': the determination of the treatment was left to the clinical judgment of the osteopath, meaning that no predefined, standa
• Другое Sham Osteopathic care
  For this trial, sham intervention will mimic the osteopathic care according to the "touch equality assumption". Therefore, it mimics a clinical examination and treatment. The sham clinical evaluation involves a full evaluation of the position and mobility of the spine.This screening of the patient will be performed using conventional osteopathic manual tests, without any intention to make a diagnosis. Sham treatment will involve light manual contact, with the subject lying supine on the treatmen
• Поведенческое Flexi-FODMAP Diet
  In addition to the real or sham osteopathic care, all participants will follow a 4-week flexi-FODMAP diet delivered online. Participants will receive structured dietary instructions via a customized online platform, based on the NHS Gentle-FODMAP diet guidelines and informed by expert input from dieticians. This modified "FODMAP-gentle" approach involves a targeted, less restrictive elimination of selected high-FODMAP foods.

Первичные конечные точки

• Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) [Срок оценки: Baseline and after 4 weeks (post-intervention)]

Вторичные конечные точки (12)

• Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• 3 day dietary dairy [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Stool Diary [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Pain intensity [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Fatigue severity [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Irritable Bowel Syndrome related quality of Life [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Gastrointestinal-Specific symptom anxiety [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Depression [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Sleep Quality [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in Perceived stress [Срок оценки: Baseline and after 4 weeks (post-intervention)]
• Change in Work Productivity and Activity [Срок оценки: Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention]
• Change in microbiota content [Срок оценки: Baseline and after 4 weeks (post-intervention)]

Критерии участия

Критерии включения

This study includes participants who meet the following criteria:

• are over 18 years old;
• 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);
• 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.

Критерии исключения

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

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Vrije Universiteit Brussel — Brussels

Публикации

• Mancini JD, Yao S, Martinez LR, Shakil H, Li TS. Gut Microbiome Changes with Osteopathic Treatment of Constipation in Parkinson's Disease: A Pilot Study. Neurology (ECronicon). 2021 Feb;13(2):19-33. Epub 2021 Jan 30. PMID 33899052
• Buffone F, Tarantino AG, Belloni F, Spadafora A, Bolzoni G, Bruini I, Bergna A, Vismara L. Effectiveness of Osteopathic Manipulative Treatment in Adults with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Aug 31;11(17):2442. doi: 10.3390/healthcare11172442. PMID 37685480
• Attali TV, Bouchoucha M, Benamouzig R. Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial. J Dig Dis. 2013 Dec;14(12):654-61. doi: 10.1111/1751-2980.12098. PMID 23981319
• Florance BM, Frin G, Dainese R, Nebot-Vivinus MH, Marine Barjoan E, Marjoux S, Laurens JP, Payrouse JL, Hebuterne X, Piche T. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):944-9. doi: 10.1097/MEG.0b013e3283543eb7. PMID 22546751

Идентификаторы

NCT: NCT07176078 · 25153_POISE-IBS-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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