Exploring the effects of a placebo probiotic on gut health and well-being
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06720558 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 20 to 65 with mild gastrointestinal symptoms that do not severely affect daily activities.
Not a fit: Patients with diagnosed functional gastrointestinal disorders or those suffering from neurodegenerative or psychiatric conditions may not benefit from this study.
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 performed: Previous studies have shown that placebos can have significant effects on health outcomes, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Milan
- Catholic University of the Sacred Heart — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Diletta Barbiani
- Email: diletta.barbiani@unicatt.it
- Phone: +393338059338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.