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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Deceptive Placebo
Intervention: 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.
Intervention: 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.
Intervention: Control-no treatment (Other)
Outcomes
Primary Outcomes
Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
Time Frame: Baseline and 3 weeks
Secondary Outcomes
- 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)
Investigators
Diletta Barbiani
Junior Assistant Professor
Catholic University of the Sacred Heart