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

Last updated: December 2, 2024
Sponsor: Catholic University of the Sacred Heart
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo probiotic

Control-no treatment

Open-Label Placebo probiotic

Clinical Study ID

NCT06720558
PlaCIBO_MtBlab
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Age between 20 and 65

  • Individuals with mild gastrointestinal symptoms (e.g., digestive issues, acidreflux, constipation) such that normal every-day activities are not severlycompromised.

Exclusion

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

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Placebo probiotic
Phase:
Study Start date:
November 20, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Catholic University of the Sacred Heart

    Milan, 20123
    Italy

    Active - Recruiting

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