Actively Recruiting

Phase Not Applicable
Age: 20Years - 65Years
All Genders
Healthy Volunteers
NCT06720558

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

Led by Catholic University of the Sacred Heart · Updated on 2024-12-06

30

Participants Needed

1

Research Sites

18 weeks

Total Duration

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AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 and 65 years
  • Individuals with mild gastrointestinal symptoms such as digestive issues, acid reflux, or constipation, without severe impact on daily activities
Not Eligible

You will not qualify if you...

  • Diagnosis of functional gastrointestinal disorders such as irritable bowel syndrome, ulcerative colitis, or chronic inflammatory bowel diseases
  • Presence of neurodegenerative diseases or psychiatric conditions
  • Currently taking probiotic supplements at enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Catholic University of the Sacred Heart

Milan, Italy, 20123

Actively Recruiting

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Research Team

D

Diletta Barbiani

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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