A Randomized Clinical Trial Evaluating Two Different Diets for IBS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Abdominal Pain Intensity
研究概览
简要总结
Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.
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, Care Provider, Investigator)
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
- •Patients with IBS-D diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease)
- •Aged 18-65 years at the time of screening
- •Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale
- •At least 80% compliance in daily diary entries during the 7-day screening period
排除标准
- •Subjects adhering to a dietary IBS-treatments such as the low-fat diet, low FODMAP diet, or gluten-free diet within the past 6 months
- •Subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
- •Subjects with a history of insulin-dependent or non-insulin-dependent diabetes
- •Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
- •Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
- •BMI < 18.5
研究组 & 干预措施
Diet A
Modified Diet A
干预措施: Diet A (Other)
Diet B
Modified Diet B
干预措施: Diet B (Other)
结局指标
主要结局
Abdominal Pain Intensity
时间窗: 28 days
Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.
次要结局
- Irritable Bowel Syndrome - Symptom Severity Score(28 days)
- Abdominal Discomfort Intensity(28 days)
- Abdominal Bloating Intensity(28 days)
- Adequate Relief(28 days)
- Composite Score(28 days)
- Stool Consistency(28 days)