Clinical trial NCT06720558: Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Gastrointestinal Symptoms
Placebo Effect
Open-Label Placebo
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
timeFrame: Baseline and 3 weeks
Secondary outcomes:
measure: Change from Baseline in the Digestion-Associated Quality Of Life Questionnaire (DQLQ) total score at 3 weeks.
timeFrame: Baseline and 3 weeks
measure: Change from Baseline in Stool Form as assessed by means of the Bristol Stool Scale
timeFrame: Day 2/3 and day 19/20 from Baseline
measure: Change from Baseline in Fatigue Levels as assessed by means of the Multidimensional Fatigue Inventory (MFI-20) at 3 weeks.
timeFrame: Baseline and 3 weeks
measure: Change from Baseline in Sleepiness Levels as assessed by means of the The Epworth sleepiness scale at 3 weeks.
timeFrame: Baseline and 3 weeks
measure: Change from Baseline in Positive and Negative affect as assessed by means of the Positive and Negative Affect Schedule (PANAS) at 3 weeks.
timeFrame: Baseline and 3 weeks
measure: Change from Baseline in Stress Levels as assessed by means of the Perceived Stress Scale (PSS) 3 weeks.
timeFrame: Baseline and 3 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
References: