Generating a Stool Microbiome-based Diagnostic for IBS (Irritable Bowel Syndrome) Patients in Low-FODMAP Treated and Untreated IBS Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- IBS-SSS - irritable bowel syndrome severity score system questionnaire
研究概览
简要总结
Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. The two main mechanisms invoking IBS development and flares include 1) an increase in luminal water content due to malabsorption of small molecules and 2) incrementation of colon gas production generated by the fermentation of small molecules by gut bacteria.Yet to date, a person-specific elucidation of the specific small molecules and bacteria driving IBS, and their downstream effects on the human gut epithelium remain unknown.
Over the past years, it became evident that dietary regimes, and their interactions with the intestinal microbiome, are at the center of IBS symptom generation and alleviation. The most widely used dietary intervention is a highly restrictive diet, the low-Fermentable Oligo-saccharides Di-saccharides Mono-saccharides And Polyols (FODMAP) diet, based on avoidance of multiple food items that contain available fermentable molecules.
The low-FODMAP diet remains an effective line of treatment for IBS patients, yet due to its complexity and unhealthy nature, it remains a last line of treatment and fails to impact the majority of IBS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Male and Female
- •Age - 18-70
排除标准
- •Consumption of antibiotics 2 months prior to the first day of the experiment.
- •Consumption of probiotic supplements 1 month prior to the first day of the experiment.
- •Type 1 or type 2 diabetes diagnosis.
- •Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the study.
- •Chronic disease - to the discretion of the study doctor.
- •Cancer and recent anticancer treatment.
- •Psychiatric disorders - to the discretion of the study doctor.
- •IBD (inflammatory bowel diseases).
- •Alcohol or substance abuse.
- •BMI > 35.
研究组 & 干预措施
Non-IBS
Participants which are not suffering from IBS symptoms.
FODMAP graduates
Individuals who have practiced a low-FODMAP diet in the past
IBS -low FODMAP
individuals that are diagnosed with IBS according to Rome IV criteria
干预措施: Low FODMAP dietary regimen (Other)
结局指标
主要结局
IBS-SSS - irritable bowel syndrome severity score system questionnaire
时间窗: 1 week
Severity of symptoms as they are scored in the Rome IV IBS-SSS 75 to \<175 to indicate mild IBS, 175 to \<300 as moderate, and \>300 as severe
IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire
时间窗: 1 week
Quality of life scores from the Rome IV IBS-QOL 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life
次要结局
- Stool microbiome differences between the study arms - using fecal samples of participants(3 months)
