跳至主要内容
临床试验/NL-OMON51091
NL-OMON51091已完成不适用

utrition to Relieve IBS symptoms by targeting the Microbiota - NUTRIMI study

Wageningen Universiteit0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - IBS patients that meet the Rome IV criteria. This will be evaluated by the
  • medical supervisor;
  • - Male and female adults, aged 18-65 years;
  • - Having a Body Mass Index (BMI) between 18.5 and 30 kg/m2;
  • - Willing to keep a stable dietary pattern throughout the study;
  • - Having a smartphone to fill out the daily questionnaires;

排除标准

  • - Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease,
  • or Ulcerative colitis;
  • - Having a history of intestinal surgery that might interfere with study
  • outcomes. This does not include an appendectomy or cholecystectomy;
  • - Having a food allergy to milk protein or pulse protein;
  • - Presence of significant systemic diseases, such as diabetes mellitus, cancer,
  • cardiovascular disease or respiratory disease;
  • - When applicable: currently pregnant or breastfeeding, or intending to become
  • pregnant during the study, as this can affect stool patterns and wellbeing;
  • - Use of antibiotic treatment less than 3 months before start of the study and
  • no use of antibiotics during the study;
  • - Use of prebiotics and/or probiotics (should be stopped 4 weeks before the
  • start of the study) and infrequent use of other (fiber) supplements. Some
  • supplements are allowed, but intake should be kept stable during the whole
  • study period (Supplements will be judged by the medical supervisor MD Ben
  • - Currently following a FODMAP-restricted diet;
  • - Use of medication that can interfere with the study outcomes, including
  • anxiolytics (antidepressants are allowed), laxatives (Over-the-counter
  • laxatives are allowed, but intake should be either stopped at least 4 weeks
  • before the start of the study or kept stable during the complete study period),
  • and codeine, as judged by the medical supervisor MD Ben Witteman;
  • - Participation in another clinical trial at the same time;
  • - Student or employee working at Food, Health and Consumer Research from
  • Wageningen Food and Biobased Research;
  • - Alcohol intake * 2 (women) or * 4 (men) glasses of alcoholic beverages per
  • Abuse of illicit drugs
  • - being incapacitated

研究者

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