The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The proportion (%) of patients who respond to treatment
研究概览
简要总结
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.
详细描述
The study is a randomized controlled trial comparing three different treatments during four weeks:
- Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations)
- Eat at regular hours; 3 main meals and 3 snacks
- Eat in peace, chew the food properly
- Peel all fruits and vegetables
- Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum
- Choose soluble rather than insoluble fibres
- Avoid foods high in FODMAPs
- Diet low in carbohydrates
- 10 E% carbohydrates, 23 E% protein, 67 E% fat
- Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables
- No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits
- No specific consideration about FODMAP content
- Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment.
Pain/discomfort:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident
排除标准
- •Heart, liver, neurologic or psychiatric disease or illness
- •Serious gastrointestinal diseases
- •Celiac disease
- •Other conditions or surgery that affects the gastrointestinal function
- •Hyperlipidemia
- •Food allergy or intolerance other than lactose
- •Adherence to a specific diet
- •Being pregnant or breastfeeding
- •Previously been treated with any of the intervention arms, including having tested all of the pharmacological treatment options of relevance for the symptom profile of the patient
结局指标
主要结局
The proportion (%) of patients who respond to treatment
时间窗: Baseline to 4 weeks
A responder is defined as having an IBS-SSS reduction \>50 points @ 4 weeks
次要结局
- Change in symptom severity(Baseline, 4 weeks, 3 and 6 months)
- Change in metabolic profile(Baseline, 4 weeks, 6 months)
- Determinants for GI symptoms by GSRS-IBS(Baseline, 4 weeks, 3 and 6 months)
- Predictors of response to treatment(Baseline to 4 weeks)
- Adherence to allocated intervention(Baseline, 4 weeks, 3 and 6 months)
- Determinants for GI symptoms by IBS-SSS(Baseline, 4 weeks, 3 and 6 months)
- Change in microbiota content(Baseline, 4 weeks, 6 months)
- Change in extra-intestinal symptoms and quality of life(Baseline, 4 weeks, 3 and 6 months)
研究者
Magnus Simrén
Professor
Sahlgrenska University Hospital