Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks
研究概览
简要总结
This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS).
The study team hypothesizes that:
- The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain
- Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief
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
- Double (Participant, Investigator)
盲法说明
Participant and investigators will not know what study cohort participants have been randomized into.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease)
- •Aged 18-70 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 percent compliance in daily questionnaire entries during the 7-day screening period
排除标准
- •Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months
- •Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
- •Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes
- •Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., 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.
- •Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy if over 6 months since these 2 procedures)
- •Oral antibiotic use in the past 3 months
- •Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
- •Currently pregnant or breastfeeding.
结局指标
主要结局
Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks
时间窗: 4 weeks
Results reflect the participants who were weekly responders for at least 2 of the 4 weeks based on their abdominal pain intensity score. The abdominal pain score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal pain and 11 represented the worst possible abdominal pain. Once per day, subjects reported their worst daily (in the past 24 hours) abdominal pain. A weekly responder was defined as a participant whose score decreased in the weekly average of worst abdominal pain in the past 24 hours by at least 30% compared with baseline.
次要结局
- Participants Who Are Weekly Responders to Stool Consistency Based on the Bristol Stool Scale (BSS) for at Least 2 of the 4 Weeks(4 weeks)
- Proportion of Participants Who Are Weekly Responders to Adequate Relief Symptom Assessment for at Least 2 of 4 Weeks(4 weeks)
- Proportion of Participants Who Are Weekly Responders Based on the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version for at Least 2 of the 4 Weeks(4 weeks)
- Change in Mean Score of the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version(Baseline, 4 weeks)
- Proportion of Participants Who Are Weekly Responders to Bloating for at Least 2 of the 4 Weeks(4 weeks)
研究者
Prashant Singh
Assistant Professor of Internal Medicine
University of Michigan