The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients
研究概览
详细说明
The study will be performed on 140 subjects with verified IBS. Patients will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study patients will fill out protocols concerning Rom IV criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales. They will be examined by a physician/researcher who will complete protocols of clinical data. Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals will go through the same procedure as described above.
Study participants with IBS will thereafter be randomized to receive an alternative diet resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130), or to continue with their regular diet (control group; n=20). 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.
Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide association studies), gut microbiota and inflammatory parameter analyses.
Statistics
To study differences in the above-mentioned parameters between patients and controls as well as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used, respectively.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Malmö、瑞典、20502
- Deartment of INternal Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Verified IBS according to Rom IV criteria.
Exclusion Criteria:
- Serious mental or somatic disease
- Abuse
- Inability to understand he Swedish language
- Already on a diet (e.g. vegan, FODMAP, gluten-free).
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Dietary intervention subject group
n=130.
Participants on low FODMAP-similar diet during 4-week study period.
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Elimination of certain products.
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无干预：Control group
n=20.
Participants on traditional IBS diet during 4-week study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Genetic variation of enzymes regulating absorption of disaccharides
大体时间：measured at baseline
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Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.
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measured at baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
大体时间：4 weeks
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Changes from baseline in subjective symptoms according to the IBS-SSS.
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4 weeks
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Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
大体时间：4 weeks
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Changes from baseline in subjective symptoms according to the VAS-IBS.
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4 weeks
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Gut microbiota composition
大体时间：4 weeks
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Changes from baseline in fecal microbiota analysed by 16rs
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4 weeks
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Cytokines
大体时间：4 weeks
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Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
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4 weeks
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microRNA expression
大体时间：4 weeks
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Changes from baseline in microRNA expression will be assessed.
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4 weeks
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合作者和调查者
赞助
调查人员
- 首席研究员：Bodil Ohlsson, MD, PhD、Region Skane
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Dietary intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人