HealthyPlaCIBONCT06720558
Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms
A study of Healthy, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of the Sacred Heart
Milan, 20123
Diletta Barbiani, +393338059338, diletta.barbiani@unicatt.it
About this study
Official 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
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
- Being tested
- Placebo probiotic, Open-Label Placebo probiotic, Control-no treatment
- Keywords
- Gastrointestinal Symptoms, Placebo Effect, Open-Label Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo probioticOther
Three-week consumption of placebo probiotic capsules passed off as being actual probiotics
Open-Label Placebo probioticOther
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 treatmentOther
For the first three weeks, the Control group will not be exposed to any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Deceptive Placebo | Experimental | Not described Receives: 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. Receives: Other: Open-Label Placebo probiotic; Other: Control-no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
Measured: Baseline and 3 weeks
Secondary outcomes (6)
Change from Baseline in the Digestion-Associated Quality Of Life Questionnaire (DQLQ) total score at 3 weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start20 Nov 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diletta Barbiani, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720558
- Sponsor's protocol ID
- PlaCIBO_MtBlab
- Acronym
- PlaCIBO
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06720558
- Acronym / sponsor ID
- PlaCIBO / PlaCIBO_MtBlab
- Conditions
- Healthy
- Keywords
- Gastrointestinal Symptoms, Placebo Effect, Open-Label Placebo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deceptive Placebo | Experimental | Other: Placebo probiotic |
| Control - Open-Label PLacebo | Other | Other: Open-Label Placebo probiotic, Other: Control-no treatmentThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo probioticThree-week consumption of placebo probiotic capsules passed off as being actual probiotics | Other | Deceptive Placebo |
| Open-Label Placebo probioticParticipants 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. | Other | Control - Open-Label PLacebo |
| Control-no treatmentFor the first three weeks, the Control group will not be exposed to any intervention. | Other | Control - Open-Label PLacebo |
Primary outcome
Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks.
Time frame: Baseline and 3 weeks
6 secondary outcomes
Change from Baseline in the Digestion-Associated Quality Of Life Questionnaire (DQLQ) total score at 3 weeks.
Time frame: Baseline and 3 weeks
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
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
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
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
Change from Baseline in Stress Levels as assessed by means of the Perceived Stress Scale (PSS) 3 weeks.
Time frame: Baseline and 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diletta Barbiani (+393338059338, diletta.barbiani@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Gastrointestinal Symptom Rating Scale (GSRS) total score at 3 weeks. (time frame: Baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.