Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Osteopathic care + flexi FODMAP diet
干预措施: Osteopathic care (Other)
Osteopathic care + flexi FODMAP diet
干预措施: Flexi-FODMAP Diet (Behavioral)
Sham osteopathic care + flexi FODMAP diet
干预措施: Sham Osteopathic care (Other)
Sham osteopathic care + flexi FODMAP diet
干预措施: Flexi-FODMAP Diet (Behavioral)
结局指标
主要结局
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
时间窗: Baseline and after 4 weeks (post-intervention)
The IBS Symptom Severity Score (IBS-SSS) will be utilized to evaluate the severity of IBS symptoms. This scale provides an overall score ranging from 0 to 500, with higher scores indicating greater symptom severity. The questionnaire includes the following components: intensity and frequency of abdominal pain, abdominal distension, dissatisfaction with bowel habits, and the overall impact of IBS on daily life ("life interference"). Scores are categorized as follows: 75-175 indicates mild severity, 175-300 represents moderate severity, and 300 or above reflects severe symptoms. The IBS-SSS considered a valid and reliable scale, with a Cronbach's Alpha = 0.80.
次要结局
- Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)(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(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(Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention)
- Change in Depression(Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention)
- Adherence to allocated intervention(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(Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention)
- Stool Diary(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(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(Baseline and after 4 weeks (post-intervention))
- Change in Irritable Bowel Syndrome related quality of Life(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(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(Baseline and after 4 weeks (post-intervention))
- Change in Work Productivity and Activity(Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention)
- Patient Satisfaction(After 4 weeks (post-intervention))