NL-OMON46540已完成不适用
IBSQUtrition: Microbiota and Metabolite Profiles Linked to Severity in Irritable Bowel Syndrome - Microbiota profiling in IBS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For IBS patients:
- •- Adults, aged 18-65 years.
- •- IBS patients that meet the Rome IV criteria.
- •- In close proximity of Wageningen (max. 50 km), for practical reasons: collection of the faecal samples.
- •- Have an Body Mass Index (BMI) between 18.5 and 30 kg/m2.
- •- Signed informed consent.
- •- After T1, IBS severity will be checked using the IBS-SSS. Subjects will be included for follow-up at T2, when they have the most mild symptoms (n<=30) or most severe (n<=30) symptoms. ;Healthy controls: will be age (±5 years), gender and BMI (±1kg/m2) matched with IBS patients. Other criteria:
- •- Adults, aged 18-65 years.
- •- No history of IBS, as assessed by the Rome IV criteria.
- •- Has a score <75 from the IBS-SSS.
- •- Are age (±5 years), gender and Body Mass Index (±1 kg/m2) matched with IBS patients.
- •- In close proximity of Wageningen (max. 50 km), for practical reasons: collection of the faecal samples.
- •- Signed informed consent.
排除标准
- •For IBS patients:
- •Presence of gastro-intestinal diseases, such as celiac disease, Crohn*s disease, or Ulcerative colitis.
- •- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- •- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- •- Female participants: currently pregnant or breast-feeding.
- •- Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study.
- •- Are not participanting in another study during this study.
- •- Are an employee or student of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiologie, of Wageningen University & Research.
- •- Unwilling or unable to fulfil study criteria.
- •- If they are not selected in the most mild or most severe group at T1. ;For healthy controls:
- •- Presence of gastro-intestinal diseases, such as celiac disease, Crohn*s disease, or Ulcerative colitis.
- •- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- •- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- •- Female subjects: currently pregnant or breast-feeding.
- •- Use of antibiotic treatment less than 3 months before start of the study.
- •- Are an employee of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiology, of Wageningen University & Research.
- •- Are subjects in another study during this study.
- •- Unwilling or unable to fulfil study criteria.
研究者
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