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

Официальное название

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

Обзор

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).

Вмешательства

• Другое Placebo probiotic
  Three-week consumption of placebo probiotic capsules passed off as being actual probiotics
• Другое 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.
• Другое Control-no treatment
  For the first three weeks, the Control group will not be exposed to any intervention.

Первичные конечные точки

• Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks. [Срок оценки: Baseline and 3 weeks]

Вторичные конечные точки (6)

• Change from Baseline in the Digestion-Associated Quality Of Life Questionnaire (DQLQ) total score at 3 weeks. [Срок оценки: Baseline and 3 weeks]
• Change from Baseline in Stool Form as assessed by means of the Bristol Stool Scale [Срок оценки: 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. [Срок оценки: Baseline and 3 weeks]
• Change from Baseline in Sleepiness Levels as assessed by means of the The Epworth sleepiness scale at 3 weeks. [Срок оценки: 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. [Срок оценки: Baseline and 3 weeks]
• Change from Baseline in Stress Levels as assessed by means of the Perceived Stress Scale (PSS) 3 weeks. [Срок оценки: Baseline and 3 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Catholic University of the Sacred Heart — Milan

Идентификаторы

NCT: NCT06720558 · PlaCIBO_MtBlab

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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