NL-OMON40415已完成不适用
Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Oligofructose on Stool Frequency in Constipated subjects - TOMCAT: Trial on Oligofructose, Microbiota, and Constipation in Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
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
- •Age 18-75 yr
- •Agree to study design (signed informed consent)
- •At least two of the following symptoms >=25% of the defecations (ROME III) with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to study start:
- •o straining, lumpy or hard stool
- •o sensation of incomplete evacuation
- •o sensation of anorectal obstruction * blockage
- •o use of manual manoeuvres
- •o <3 bowel movements per week
- •Availability of internet connection
- •BMI 20-30
- •Male and/or female
- •Willingness to abstain from functional ingredients and such as probiotics, prebiotics, foods containing high amounts of fermentable fibers, and laxatives during the study.
排除标准
- •Currently participating in another clinical trial
- •Drug usage
- •Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week)
- •Pregnancy or lactating
- •Underlying disease of the GI-tract or previous laparotomy, except cholecystectomy and appendectomy.
- •Use of antibiotics within 1 month prior to inclusion
- •Vegetarians
- •Weight loss >5 kg within 1 month prior to inclusion
研究者
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