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

NCT ID: NCT06720558

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy

Keywords

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Gastrointestinal Symptoms Placebo Effect Open-Label Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Deceptive Placebo

Group Type EXPERIMENTAL

Placebo probiotic

Intervention Type OTHER

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

Control - Open-Label PLacebo

The Control Arm will not be exposed to any intervention for the first three weeks. After this time and for the following three weeks, participants will receive placebo probiotic pills in an open-label fashion: they will be honestly informed that the pills are inert placebos.

Group Type OTHER

Open-Label Placebo probiotic

Intervention Type OTHER

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.

Control-no treatment

Intervention Type OTHER

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

Interventions

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Placebo probiotic

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

Intervention Type 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.

Intervention Type OTHER

Control-no treatment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Diletta Barbiani

Junior Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of the Sacred Heart

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Diletta Barbiani

Role: CONTACT

Phone: +393338059338

Email: [email protected]

Facility Contacts

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Diletta Barbiani

Role: primary

Other Identifiers

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PlaCIBO_MtBlab

Identifier Type: -

Identifier Source: org_study_id