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

NCT06720558 | Recruiting

• 1 other identifier: PlaCIBO_MtBlab
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Gastrointestinal Symptoms; Placebo Effect; Open-Label Placebo

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 3 weeks

Secondary Outcomes (6)

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

  Baseline and 3 weeks

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

  Day 2/3 and day 19/20 from Baseline

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

  Baseline and 3 weeks

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

  Baseline and 3 weeks

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

  Baseline and 3 weeks

Study Arms (2)

Deceptive Placebo

EXPERIMENTAL

Other: Placebo probiotic

Control - Open-Label PLacebo

OTHER

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.

Other: Open-Label Placebo probiotic; Other: Control-no treatment

Interventions

Placebo probiotic OTHER

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

Deceptive Placebo

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 - Open-Label PLacebo

Control-no treatment OTHER

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

Control - Open-Label PLacebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Milan, 20123, Italy

RECRUITING

Central Study Contacts

Diletta Barbiani

CONTACT

+393338059338; diletta.barbiani@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Assistant Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 6, 2024
• Study Start: November 20, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)