Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms
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
Catholic University of the Sacred Heart
30 participants
Nov 20, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria2
- 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 Criteria3
- 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
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Interventions
Three-week consumption of placebo probiotic capsules passed off as being actual probiotics
Participants of the Control group will be switched to this condition after three weeks and receive placebo probiotic capsules for the following three-weeks of no intervention. Specifically, they will be honestly informed that the capsules are inert placebos.
For the first three weeks, the Control group will not be exposed to any intervention.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06720558