The Effects Of Probiotics On Stress And Bowel Habits Among Healthy Adults From Umm Al-Qura University at Makkah: A Randomized Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Bowel function
研究概览
简要总结
The goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy Saudi adults for both males and females.
The main questions it aims to answer are:
Does probiotic supplementation decrease stress levels? Does probiotic supplementation improve bowel habits?
Researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.
详细描述
Participants were required to
- Attend a visit to the nutrition clinic at Umm AL-Qura University to assess for eligibility.
- Eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected
- Participants were randomized based on lottery based method to an interventional or control group
- Intervention group received 30 capsules of probiotics (Lactobacillus rhamnosus GG, 6x10^9 cpu) to be taken once daily
- After 30 days, all participants had to attend a second visit at the nutrition clinic at Umm Al-Qura University to assess stress levels, bowel habits and receive their incentives (discount voucher of restaurants).
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students at Umm Al-Qura University
- •Age ≥ 18 years
- •Healthy individuals
- •Both genders
- •Saudi nationality
排除标准
- •Diagnosed with chronic illness or/and psychiatric condition
- •Consumption of medications or supplements in the previous 3 months
- •Pregnant and breastfeeding
结局指标
主要结局
Bowel function
时间窗: Post intervention at 30 days
The questionnaire was developed to collect, comorbid illnesses, a prescription list, and specific questions related to bowel habits including fluid intake, usual diet, fecal matter consistency, frequency of defecation, and straining. The questionnaire also contained questions about laxative usage, previous surgeries, and lifestyle. The questionnaire was translated by an authorised translator and was based on a previous study.
Stress
时间窗: Post intervention at 30 days
Perceived stress scale (PSS) was used in both English and Arabic versionsndividual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
次要结局
未报告次要终点
研究者
Essra Noorwali
Associate Professor
Umm Al-Qura University