Clinical trial Recruiting at 1 site Interventional Ages 20 to 65

Exploring the effects of a placebo probiotic on gut health and well-being

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

Run by Catholic University of the Sacred Heart · NCT06720558 · Data updated 2026-11-12

This study is testing if taking a fake probiotic that people think is real can help improve gut health and overall well-being in healthy individuals with mild stomach issues.

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Quick facts

Study typeInterventional
Ages20 Years to 65 Years
SexAll
Enrollment30 (estimated)
SponsorCatholic University of the Sacred Heart
Academic / other
Locations1 site (Milan)
StatusRecruiting
StartedNovember 20, 2024
Main results expectedApril 2025
Study endsApril 2025
Registry record updatedDecember 6, 2024
Trial IDNCT06720558 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy individuals aged 20 to 65 with mild gastrointestinal symptoms that do not severely affect daily activities.

Probably not a fit

Patients with diagnosed functional gastrointestinal disorders or those suffering from neurodegenerative or psychiatric conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether positive expectations of receiving a probiotic supplement, which is actually a placebo, can improve gastrointestinal symptoms and enhance overall well-being in healthy individuals experiencing mild gastrointestinal distress. Participants will be divided into two groups: one receiving a deceptive placebo and another receiving no treatment initially. After a waiting period, the control group will be offered the placebo in an open-label manner, where they will be informed that the pills are inert. The study aims to compare the effects of the deceptive placebo against the open-label placebo and assess any significant improvements in symptoms and well-being.

Why it matters

Potential benefit: If successful, this study could provide insights into the psychological impact of placebos on gastrointestinal health and overall well-being.

How similar studies have gone: Previous studies have shown that placebos can have significant effects on health outcomes, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Catholic University of the Sacred Heart
    Milan, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.