跳至主要内容
临床试验/NCT05972317
NCT05972317招募中不适用

Generating a Stool Microbiome-based Diagnostic for IBS (Irritable Bowel Syndrome) Patients in Low-FODMAP Treated and Untreated IBS Patients

Weizmann Institute of Science1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5月11日最近更新:
适应症
干预措施

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

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

No Intervention

Participants which are not suffering from IBS symptoms.

FODMAP graduates

No Intervention

Individuals who have practiced a low-FODMAP diet in the past

IBS -low FODMAP

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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