Whole Genome Association Study (GWAS) to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of Irritable Bowel Syndrome (IBS) Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Find single nucleotide polymorphisms (SNPs) that associate with the diet respone
研究概览
简要总结
This is a GWAS that aims to identify possible single nucleotide polymorphisms (SNPs) that are associated with the response in a combined dietary pattern low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and Meditteranean diet (MED-LFD) in a small group of patients with Irritable Bowel Syndrome (IBS).
详细描述
Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Several factors seem to contribute to its development, such as psychological stress, intestinal dysbiosis, infections, post-traumatic syndrome and genetic predisposition. Regarding the nutritional management of IBS, there are several approaches to alleviate symptoms, such as the low-fructose diet low in fermentable oligosaccharides, disaccharides, monosaccharides and FODMAP polyols (LFD), recommendations from the British Institute of Health and Care Excellence (NICE) and the recently proposed combination of the Mediterranean diet and LFD (MED-LFD) proposed by our Research Group. However, genetic background expressed in single nucleotide polymorphisms (SNPs) appears to influence the response to even dietary interventions.
The aim of this GWAS is to identify SNPs that are associated with the negative or positive response to the diet.
At the baseline, blood samples will be collected for DNA extraction. Genotyping will be based on Next Generation Sequencing (NGS) technology to detect genetic factors associated with the effectiveness of the intervention. Symptom severity will be measured by the IBS-SSS scale. Mental health status will be assessed with the HADS (Hospital Anxiety and Depression Scale) questionnaire.
Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of the Rome IV criteria for IBS
- •Provision of written informed consent.
- •Commitment of availability throughout the study period.
- •IBS-SSS > 175
排除标准
- •Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).
- •Pregnancy.
- •Breastfeeding.
结局指标
主要结局
Find single nucleotide polymorphisms (SNPs) that associate with the diet respone
时间窗: Baseline
Blood samples will be collected for DNA extraction. Genotyping be based on Next Generation Sequencing (NGS). Quality control (QC) filtering will be applied at individual-and variant-level using specialized software.
次要结局
- Evaluation of the effect of interventions on gut microbiota composition between groups.(Baseline and through study completion (an average of 1 year))
- Change of symptoms severity pre and post intervention using a specialized questionnaire.(Baseline and through study completion (an average of 1 year))
- Assessment of general quality of life pre and post intervention between groups(Baseline and through study completion (an average of 1 year))
- Assessment of symptoms burden in general pre and post intervention.(Baseline and through study completion (an average of 1 year))
- Assessment of anxiety and depression disorders pre and post intervention.(Baseline and through study completion (an average of 1 year))
研究者
Arezina Kasti
PhD candidate - Head of Clinical Nutrition Department of Attikon Hospital
Attikon Hospital