Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Change in Fecal Microbiota
研究概览
简要总结
Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults with a Body mass index (BMI) of 16.00 to 29.99 kg/m2
- •Self-reported constipation according to the Rome IV criteria
排除标准
- •Pregnancy
- •Crohn's disease or any other inflammatory bowel disease
- •Pelvic floor dyssynergia
- •Have congenital diseases such as liver disease, diabetes, and thyroid dysfunction. hypercalcemia neurological disease
- •Drink alcohol or smoke regularly.
- •During the past 1 month or while in the project, have received antibiotics, steroids, NSAIDs, blood pressure-lowering drugs, antidepressants, anticonvulsants, or Parkinson's disease medications
- •History of food allergy to Haruna's ingredients
- •There has been a change in body weight (increase or decrease of 5 kilograms over a period of 6 months).
- •During the past 2 weeks or while in the project, have received probiotics or other prebiotics
研究组 & 干预措施
Prebiotic arm
干预措施: Haruna (Dietary Supplement)
Placebo arm
干预措施: Placebo Powder (Dietary Supplement)
结局指标
主要结局
Change in Fecal Microbiota
时间窗: 12 weeks
Change in Bifidobacterium relative abundance with 2log ratio of relative abundance, during the intervention period, compared between prebiotic arm and placebo arm. Subjects with an increase in Bifidobacterium relative abundance were considered to have a good response.
Change in Stool Frequency
时间窗: 12 weeks
Stool frequency during the intervention period was determined by modified Constipation scoring system using questionnaire with the following variables: frequency of bowel movements; painful evacuation effort; feeling of incomplete evacuation; abdominal pain; minutes in lavatory per attempt; type of assistance; unsuccessful attempts for evacuation. This consists of six items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 26 (severe constipation).
次要结局
- Change in Stool consistency(12 weeks)
研究者
Sirirat Luk-In
Assistant professor
Mahidol University