Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms (PlaCIBO)

Catholic University of the Sacred Heart

Status: Enrolling

Conditions: Healthy

Treatments: Other: Placebo probiotic; Other: Control-no treatment; Other: Open-Label Placebo probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06720558

PlaCIBO_MtBlab

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Deceptive Placebo

Experimental group

Treatment:

Other: Placebo probiotic

Control - Open-Label PLacebo

Other group

Description:

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.

Treatment:

Other: Open-Label Placebo probiotic

Other: Control-no treatment