NCT06720558 Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms
| NCT ID | NCT06720558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catholic University of the Sacred Heart |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-11-20 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06720558 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06720558 currently recruiting?
Yes, NCT06720558 is actively recruiting participants. Contact the research team at diletta.barbiani@unicatt.it for enrollment information.
Where is the NCT06720558 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06720558 clinical trial?
NCT06720558 is sponsored by Catholic University of the Sacred Heart. The trial plans to enroll 30 participants.