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

NCT06720558 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-06

No results posted yet for this 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).

Conditions

  • Healthy

Interventions

OTHER

Placebo probiotic

Three-week consumption of placebo probiotic capsules passed off as being actual probiotics

OTHER

Open-Label Placebo probiotic

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.

OTHER

Control-no treatment

For the first three weeks, the Control group will not be exposed to any intervention.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720558 on ClinicalTrials.gov