Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Region Skane
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Efficiency on bowel and extra-intestinal symptoms
研究概览
简要总结
The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.
详细描述
The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.
Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.
The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.
The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.
Statistics
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
- None
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
- •Verified IBS according to Rom IV criteria.
排除标准
- •Serious mental disease
- •Serious somatic disease
- •Inability to understand the Swedish language
- •Already on a diet
研究组 & 干预措施
Dietary intervention with Low FODMAP
The participants are given oral and written instructions on which diet that contains low contents of FODMAP.
干预措施: low FODMAP or SSRD (Dietary Supplement)
Dietary intervention with SSRD
The participants are given oral and written instructions on which diet that contains SSRD.
干预措施: low FODMAP or SSRD (Dietary Supplement)
结局指标
主要结局
Efficiency on bowel and extra-intestinal symptoms
时间窗: A follow-up 5 months after the end of the intervention
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of IBS-SSS. This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms
时间窗: A follow-up 5 months after the end of the intervention
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel and extra-intestinal symptoms
时间窗: 4 weeks dietary intervention
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms
时间窗: 4 weeks dietary intervention
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
次要结局
- Effects on phosphorous(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on metabolomics and proteomics(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on gut microbiota by whole genome sequencing of feces(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on microRNA(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on DNA methylation(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects depending on genetics(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on plasminogen activator inhibitor-1 (PAI-1)(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on insulin(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on leptin(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on vitamin A(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on healthcare consumption(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on C-peptide(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on vitamin D(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on magnesium(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on gastric inhibitory peptide (GIP)(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on visfatin(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on ghrelin(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on zinc(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on vitamin B(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on vitamin C(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on albumin(4 weeks dietary intervention, with a follow-up after another 5 months)
- Effects on eating disturbances(4 weeks dietary intervention, with a follow-up after another 5 months)