Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
研究概览
简要总结
The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).
详细描述
This is a parallel group, randomized control trial, powered to assess changes in validated outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-70 years of age.
- •Irritable Bowel Syndrome by Rome III criteria.
- •Stable dose (30 days) of concurrent IBS medications
- •Agree not to make significant changes to their diet during the study
- •IBS-SSS score of >150
排除标准
- •History of major abdominal surgeries
- •History of inflammatory bowel disease
- •Antibiotic use within 1 month of enrollment
- •Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function
- •Current use of opioid pain medications (except for NSAIDs)
- •Previous experience participating in dietary studies for IBS
- •Current use of medications which are known to be affected by modest dietary changes
- •Vitamin C use of >2000 mg/day
- •Quercetin use of >500 mg/day
研究组 & 干预措施
Intervention Diet
Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
干预措施: Personalized Dietary Advice (Other)
Active control diet
Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
干预措施: Personalized Dietary Advice (Other)
结局指标
主要结局
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
时间窗: 8 weeks
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
次要结局
- Irritable Bowel Syndrome Adequate Relief (IBS-AR)(8 weeks)
- Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)(8 weeks)
- Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)(8 weeks)