Fiber and Water Improve Bowel Habit and Stool Microbiota in Healthy Participants: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- bowel habit: straining
研究概览
简要总结
Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of life, fecal characteristics and microbiota) measured during a week of monitoring followed by randomization to a 14 days course of increased fiber in diet or increased fiber and water intake, with repetition of parameters measuring at the end.
详细描述
Demographic and clinical data were collected and recorded in the first interview after signing the informed consent. The protocol was composed of two phases. The baseline phase lasted 7 days, when participants reported their usual diet on a food dairy in the first 3 days, between Sunday and Tuesday. Calculation of nutrient intake was performed using ADS nutri software (UFPEL, Pelotas, Brazil). Participants approved for the next phase were then randomized to fiber and fiber+water groups, which lasted 14 days. During this period participants were asked to report their intestinal habits including bowel movements, graduation of straining and subjective stool consistency. Participants were instructed to rank straining using a Likert scale from 1 (minimum) to 5 (maximum), and the Bristol scale for stool consistency. In the last day of treatment phase (Saturday) participants collected feces and urine of 24 hours, and responded a symptoms questionnaire. Food and liquid intake were recorded on a diary during the last 3 days of treatment for comparison with the baseline phase stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-obese
- •absence of abdominal complaints
排除标准
- •use of medications that interfere with the gastrointestinal tract function
- •past of abdominal surgery
- •any acute or chronic disease
研究组 & 干预措施
Fiber
Participants were treated with 2 sachets of fiber orally a day for 14 days, after baseline characterization of bowel habit and stool features.
干预措施: Fiber (Dietary Supplement)
Fiber and Water
Participants were treated with 2 sachets of fiber orally a day and ingested 2 liters of water a day for 14 days, after baseline characterization of bowel habit and stool features.
干预措施: Fiber and Water (Dietary Supplement)
结局指标
主要结局
bowel habit: straining
时间窗: 14 days
The patient reported the effort for each evacuation using a Likert scale between 1 and 5 (1 = no effort / 5 = maximal) during 14 days of experimental use of fiber or fiber+water
bowel habit: stool consistency
时间窗: 14 days
The patient reported the stool consistency of evacuations using a Bristol scale during 14 days of experimental use of fiber or fiber+water
bowel habit: evacuation frequency
时间窗: 14 days
The patient reported in a diary the number of evacuations per day during 14 days of experimental use of fiber or fiber+water
次要结局
- Stool characteristics: fecal weight(14 days)
- Stool characteristics: percentage of water(14 days)
- Abdominal symptoms(14 days)
- Stool characteristics: pH(14 days)
- Intestinal microbiota(14 days)
研究者
Fernando Fornari
Professor
Universidade de Passo Fundo