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NCT Number: NCT06720558

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

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).

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of the Sacred Heart

Milan, 20123, Italy

Location status: Recruiting

Location contact

Diletta Barbiani

CONTACT

[email protected]

+393338059338

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo probiotic

Other

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

Open-Label Placebo probiotic

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

Other

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

Primary outcomes

  1. Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.

    Time frame: Baseline and 3 weeks

Secondary outcomes

  1. Change from Baseline in the Digestion-Associated Quality Of Life Questionnaire (DQLQ) total score at 3 weeks.

    Time frame: Baseline and 3 weeks

  2. Change from Baseline in Stool Form as assessed by means of the Bristol Stool Scale

    Time frame: Day 2/3 and day 19/20 from Baseline

    The Bristol stool scale is a diagnostic medical tool designed to classify the form of human stool into seven categories.

  3. Change from Baseline in Fatigue Levels as assessed by means of the Multidimensional Fatigue Inventory (MFI-20) at 3 weeks.

    Time frame: Baseline and 3 weeks

    Items are scored 1-5, with 10 [fatigue-]positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). In the final score, high scores represent more fatigue.

  4. Change from Baseline in Sleepiness Levels as assessed by means of the The Epworth sleepiness scale at 3 weeks.

    Time frame: Baseline and 3 weeks

    Final total score ranges from 0 to 24. Scores from 0 to 10 show average (normal) daytime sleepiness. A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.

  5. Change from Baseline in Positive and Negative affect as assessed by means of the Positive and Negative Affect Schedule (PANAS) at 3 weeks.

    Time frame: Baseline and 3 weeks

  6. Change from Baseline in Stress Levels as assessed by means of the Perceived Stress Scale (PSS) 3 weeks.

    Time frame: Baseline and 3 weeks

    The scale comprises of 10 items, with scores ranging from 0 ( = Never) to 4 ( = Very Often). Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.

Study contacts

Contact information is provided by the study sponsor or research team.

Diletta Barbiani

CONTACT

[email protected]

+393338059338

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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

Acronym: PlaCIBO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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