Trial of Mindfulness-based Irritable Bowel Syndrome Eating Awareness Training as Compared to the Standard Low Fermentable Oligosaccharide, Disaccharide, Monosaccharide and Polyol Diet in Patients With Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Global Improvement Scale (GIS) Scores Week 1
研究概览
简要总结
The study aims to compare the effect of mindfulness-based awareness training in Irritable Bowel Syndrome (IBS) (MB-IBS-EAT) with the dietary standard of care (low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet) on patient's IBS symptoms
详细描述
This pilot study will be a randomized parallel trial comparing MB-IBS-EAT done over an 8-week period to a standard low FODMAP diet. The low FODMAP diet is currently employed by clinicians as a treatment for IBS, but response rates are poor, without documented long-term benefit. This finding supports the need for better, longer lasting 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
- Single (Investigator)
盲法说明
The principal investigator will be blinded for the duration of the study. The study psychologist and the dietician will be blinded to the study results for the duration of the study.
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
- •Aged 18 and over
- •Meets Rome IV criteria for diagnosis of Irritable Bowel Syndrome (IBS)
- •Has legal and mental capacity to understand and sign an informed consent document
- •Access to a computer or smart device with internet
排除标准
- •Pregnancy
- •Active malignancy in the previous five years
- •Current or prior history of alcohol or drug abuse as defined by clinician
- •Any history of eating disorder such as anorexia or bulimia
- •Taking yoga or with prior history of mindfulness therapy within 3 months of enrollment
- •Currently on a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
- •Psychiatric illnesses other than depression or anxiety disorder
- •Nausea or vomiting
研究组 & 干预措施
Mindfulness Training
Behavioral: Mindfulness-based Eating Awareness Training in IBS - The MB-IBS-EAT is an 8-week intervention with weekly 1-hour sessions in a web-based group format.
干预措施: Mindfulness-based Attention Training in IBS (Behavioral)
fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
Dietary: Low FODMAP Diet - Subjects in the FODMAP group will be provided dietary instructions by a registered dietician during weekly 1-hour sessions in a web-based group format.
干预措施: Low FODMAP Diet (Other)
结局指标
主要结局
Global Improvement Scale (GIS) Scores Week 1
时间窗: Week 1
The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"
Global Improvement Scale (GIS) Scores Week 8
时间窗: Week 8
The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"
Global Improvement Scale (GIS) Scores Week 12
时间窗: Week 12
The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"
Global Improvement Scale (GIS) Scores Week 4
时间窗: Week 4
The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"
Global Improvement Scale (GIS) Scores Baseline
时间窗: Baseline
The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"
次要结局
- Change in cortisol blood levels(Baseline and Week 8)
- Change in Irritable bowel syndrome symptom severity (IBS-SSS) Scores(Baseline, Week 1, Week 4, Week 8, and Week 12)
- Change in Perceived Stress Level (PSS) Scores(Baseline, Week 1, Week 4, Week 8, and Week 12)
- Change in Mindful Eating Questionnaire (MEQ) Scores(Baseline, Week 8, and week 12)
- Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scores(Baseline, Week 4, Week 8, and Week 12)
- Change in Five Factor Mindfulness Questionnaire (5FMQ) Scores(Baseline, Week 4, Week 8, and Week 12)
- Change in Hospital Anxiety and Depression Scale (HADS) Scores(Baseline, Week 1, Week 4, Week 8, and Week 12)
- Change in Positive and Negative Affect Schedule (PANAS_State) Questionnaire Scores(Baseline, Week 8, and Week 12)
- Change in cytokine blood levels(Baseline and Week 8)
- Change in serotonin blood levels(Baseline and Week 8)
- Gastroparesis Cardinal Symptom Index (GCSI) Scores(Baseline, Week 1, Week 4, Week 8, and Week 12)