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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deceptive Placebo | Experimental |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo probiotic | Other | Three-week consumption of placebo probiotic capsules passed off as being actual probiotics |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks. | Baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The Bristol stool scale is a diagnostic medical tool designed to classify the form of human stool into seven categories. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diletta Barbiani | Contact | +393338059338 | diletta.barbiani@unicatt.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of the Sacred Heart | Recruiting | Milan | 20123 | Italy |
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| 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. |
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| Control-no treatment | Other | For the first three weeks, the Control group will not be exposed to any intervention. |
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| 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. | 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. | Baseline and 3 weeks |
| Change from Baseline in Sleepiness Levels as assessed by means of the The Epworth sleepiness scale at 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. | 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 |
| Change from Baseline in Stress Levels as assessed by means of the Perceived Stress Scale (PSS) 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. | Baseline and 3 weeks |