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

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06720558
• Lead Sponsor: Catholic University of the Sacred Heart

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-20
• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.	Baseline and 3 weeks

Secondary Outcome Measures

Name	Time	Method
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	The Bristol stool scale is a diagnostic medical tool designed to classify the form of human stool into seven categories.
Change from Baseline in Fatigue Levels as assessed by means of the Multidimensional Fatigue Inventory (MFI-20) at 3 weeks.	Baseline and 3 weeks	Items are scored 1-5, with 10 \[fatigue-\]positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). In the final score, high scores represent more fatigue.
Change from Baseline in Sleepiness Levels as assessed by means of the The Epworth sleepiness scale at 3 weeks.	Baseline and 3 weeks	Final total score ranges from 0 to 24. Scores from 0 to 10 show average (normal) daytime sleepiness. A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.
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	The scale comprises of 10 items, with scores ranging from 0 ( = Never) to 4 ( = Very Often). 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.

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Milan, Italy