NCT07202481招募中不适用
Effects of Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit Time in Women Diagnosed With Functional Constipation: A Randomized, Crossover, Double-Blind Clinical Trial
Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年3月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Colonic transit time
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of dietary fibers in the treatment of functional constipation in women. It will also assess the potential side effects associated with fiber consumption. The main questions it aims to answer are:
- In women with constipation who do not consume adequate dietary fiber, does supplementation help improve bowel function?
- Among the fibers studied, is there any hierarchy of effect in the treatment of constipation (i.e., is one more effective than the other)?
The researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact.
Participants will:
- Consume 20 g of fiber daily for 6 days, divided into two doses of 10 g each.
- Attend a nuclear medicine visit at the end of each 6-day fiber period to perform scintigraphy.
- Keep a daily record of bowel habits and dietary intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-59 years.
- •Willingness to sign the Informed Consent Form .
- •No restrictions on the consumption of egg or gluten.
- •No history or diagnosis of gastrointestinal diseases other than functional constipation.
- •Non-smokers.
- •No use of prebiotics, probiotics, synbiotics, or antibiotics at least 10 days prior to the study.
- •No previous surgery affecting gastrointestinal transit.
- •Willingness to discontinue the use of laxatives at least 4 days prior to scintigraphic imaging.
- •Participants who do not consume adequate dietary fiber (25-30 g/day) as assessed by dietary recall.
- •No confirmed or suspected pregnancy during the study.
- •No self-reported menopause
排除标准
- •Diagnosis of diabetes, severe hyperthyroidism, or hypothyroidism.
- •Use of opioid medications.
- •Delayed gastric emptying at 4 hours during the placebo period (participants meeting this criterion will be excluded from final analysis).
结局指标
主要结局
Colonic transit time
时间窗: This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest.
Colonic transit time will be measured using scintigraphy 24 hours after ingestion of the radiolabeled test meal.
次要结局
- Gastric emptying(This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest)
- Bowel function(The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest.)
- Quality of life assessment(Assessed at baseline and following each treatment phase of the crossover trial)
- Fecal microbiota(Baseline and at the end of each 6-day intervention period)
- Fecal Short chain fatty acids(Baseline and at the end of each 6-day intervention period)
研究者
Maria Isabel Toulson Davisson Correia
PhD
Federal University of Minas Gerais
研究点 (1)
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