A 3-week Randomized Controlled Trial on the Efficacy of a Placebo Probiotic in Rebalancing Gut Health and Fostering Physical and Emotional Well-being in Individuals With Mild Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
研究概览
简要总结
The present study is aimed at exploring whether positive expectations of receiving a three-week treatment with a probiotic supplement (in fact a placebo) improve symptoms of gastrointestinal distress and promote physical and emotional well-being in healthy individuals with mild gastrointestinal symptoms. At first, a comparison is planned between (1) a classic deceptive placebo manipulation (Deceptive Placebo group, DP), and (2) a control condition (Control group, C), in which no placebo substance will be administered. After the three-week waiting list, the Control group will be invited to take the placebo probiotic pills in an "open-label" fashion (Open Label Placebo, OLP). Specifically, participants will be informed that the pills are inert placebos. An exploratory analysis will help to clarify whether the OLP paradigm leads to significant effects, based on a within-group (C- OLP) and between-group comparison (DP-OLP).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 65
- •Individuals with mild gastrointestinal symptoms (e.g., digestive issues, acid reflux, constipation) such that normal every-day activities are not severly compromised.
排除标准
- •Individuals with a diagnosis of functional gastrointestinal disorders (e.g., irritable bowel syndrome, ulcerative colitis, chronic inflammatory bowel diseases).
- •Individuals suffering from neurodegenerative diseases and/or psychiatric conditions
- •Individuals taking probiotic supplementation at the time of enrollment in the study
研究组 & 干预措施
Deceptive Placebo
干预措施: Placebo probiotic (Other)
Control - Open-Label PLacebo
The Control Arm will not be exposed to any intervention for the first three weeks. After this time and for the following three weeks, participants will receive placebo probiotic pills in an open-label fashion: they will be honestly informed that the pills are inert placebos.
干预措施: Open-Label Placebo probiotic (Other)
Control - Open-Label PLacebo
The Control Arm will not be exposed to any intervention for the first three weeks. After this time and for the following three weeks, participants will receive placebo probiotic pills in an open-label fashion: they will be honestly informed that the pills are inert placebos.
干预措施: Control-no treatment (Other)
结局指标
主要结局
Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
时间窗: Baseline and 3 weeks
次要结局
- Change from Baseline in the Digestion-Associated Quality Of Life Questionnaire (DQLQ) total score at 3 weeks.(Baseline and 3 weeks)
- Change from Baseline in Stool Form as assessed by means of the Bristol Stool Scale(Day 2/3 and day 19/20 from Baseline)
- Change from Baseline in Fatigue Levels as assessed by means of the Multidimensional Fatigue Inventory (MFI-20) at 3 weeks.(Baseline and 3 weeks)
- Change from Baseline in Sleepiness Levels as assessed by means of the The Epworth sleepiness scale at 3 weeks.(Baseline and 3 weeks)
- Change from Baseline in Positive and Negative affect as assessed by means of the Positive and Negative Affect Schedule (PANAS) at 3 weeks.(Baseline and 3 weeks)
- Change from Baseline in Stress Levels as assessed by means of the Perceived Stress Scale (PSS) 3 weeks.(Baseline and 3 weeks)
研究者
Diletta Barbiani
Junior Assistant Professor
Catholic University of the Sacred Heart