A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet
研究概览
简要总结
Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. Over 80% of individuals with IBS report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line therapy.
There is emerging data suggesting that the Mediterranean diet may also improve the symptoms of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. Given the relative ease of implementing the Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in IBS is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies.
The investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization, participants will complete validated questionnaires to assess changes in IBS symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS Symptom Severity Scale(IBS-SSS) > 75
- •Online access
- •English literate
排除标准
- •Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease, microscopic colitis, bile acid diarrhoea)
- •Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
- •History of eating disorder
- •Body mass index <20
- •Current dietary interventions
- •Current use of opioids/antibiotics
- •Titrating dose of neuromodulators
- •Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations
- •Diabetes mellitus
- •Scleroderma
- •Memory impairment
结局指标
主要结局
Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet
时间窗: Baseline to Week 6
IBS symptom severity scale (IBS-SSS) where a 50-point reduction denotes a meaningful clinical response
次要结局
- Changes in Somatic Symptom reporting(Baseline to Week 6)
- Changes in quality of life(Baseline to Week 6)
- Adherence to the Mediterranean diet(Week 6)
- Changes in nutritional intake(Baseline to Week 6)
- Changes in individual items of the IBS-SSS(Baseline to Week 6)
- Changes in Anxiety and Depression(Baseline to Week 6)
- Dietary satisfaction to assigned intervention(Week 6)