NL-OMON50958已完成不适用
utrition to relieve IBS constipation - NUTRIC study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
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 + additional criteria specific
- •for the constipation-predominant subtype.
- •* Male and female adults, aged 18-70 years.
- •* Have a Body Mass Index (BMI) between 18.5 and 30 kg/m2 (self-reported).
- •* 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 disease that may interfere with the outcomes of this study,
- •such as a known autonomic disorder, inflammatory bowel disease, coeliac
- •disease, cancer, dialysis patients, chronic kidney failure, depression or
- •hypothyroidism.
- •* History of intestinal surgery (excluding appendectomy or cholecystectomy) or
- •endometriosis.
- •* Use of medication that can interfere with the study outcomes, including
- •antidepressants (allowed when it is not subscribed for mental depression),
- •codeine, and antibiotics, as judged by the medical supervisor MD Ben Witteman.
- •* Use of prescribed laxatives. Over-the-counter laxatives are allowed, but
- •intake should be either stopped before the start of the study or kept stable
- •during the complete study period.
- •* Use of prebiotics and/or probiotics (should be stopped 4 weeks before the
- •start of the study) and infrequent use of other (fiber) supplements dedicated
- •to bowel function improvements. 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 Witteman).
- •* If applicable: currently pregnant or breastfeeding, or intending to become
- •pregnant during the study, as this can affect stool pattern and wellbeing.
- •* Participation in another clinical trial at the same time.
- •* Student or employee working at Food, Health and Consumer Research from Food
- •and Biobased Research, or Department of Human Nutrition & Health, Wageningen
- •University.
- •* Alcohol intake * 2 (women) or * 4 (men) glasses of alcoholic beverages per
- •* Abuse of illicit drugs, soft drugs, and nitrous oxide.
研究者
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