HealthyNCT07362251
Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults
A study testing Probiotic in people with Healthy, run by University of Thessaly at 1 site in Greece.
Trial summary
The goal of this clinical trial is to examine the compliance and acceptability of the probiotic Smile Probio 45B in healthy adults, as well as its effect on gastrointestinal symptoms, fatigue levels, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 19 May 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Body Mass Index (BMI) >18 kg/m² and <30 kg/m²
- No use of antibiotics in the past month
- Willingness to provide informed consent
Who cannot join
- Pregnancy or breastfeeding
- Age under 18 years
- Diagnosis of a chronic autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis)
- Diagnosis of type I or II diabetes
- Current use of immunosuppressive medications
- Current use of antibiotics or use of antibiotics within the past month
Show all 11Show fewer
- Current use of other supplements such as probiotics, prebiotics, or synbiotics
- Kidney or liver disease
- Self-reported allergy to any component of the probiotic
- Psychological conditions affecting the ability to provide informed consent (e.g., dementia, psychosis, substance use)
- Gastrointestinal surgery within the last 6 months
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Physical Education, Sport Science and Dietetics
Trikala, Thessaly, 42132
About this study
Official title: Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study
The goal of this clinical trial is to examine the compliance and acceptability of the probiotic Smile Probio 45B in healthy adults, as well as its effect on gastrointestinal symptoms, fatigue levels, and quality of life.
Specifically, the study examines the effect of probiotic intake on improving health-related quality of life, reducing self-reported gastrointestinal symptoms such as bloating, as well as regulating stool consistency and frequency. In addition, its impact on participants' self-reported energy levels is investigated, with a particular emphasis on reducing fatigue symptoms.
Read more
Participants will:
- take 1 capsule daily (with a main meal) during the first and second week of the intervention, and 3 capsules daily (after each main meal) during the third and fourth week of the intervention, for a total duration of 30 days.
- complete a three-day food record on a weekly basis.
- record their daily bowel habits, including the number of bowel movements and their consistency/form, according to the Bristol Stool Chart, which will be provided to them.
- complete questionnaires assessing health-related quality of life [WHOQOL-BREF (World Health Organization Quality of Life)],a health status questionnaire [EQ-5D (EuroQol-5D)] and a questionnaire evaluating energy levels and fatigue [Chalder Fatigue Scale (CFQ)].
- complete, at baseline and at the end of each intervention week a weekly symptom assessment questionnaire.
- undergo body composition assessment at the beginning, midpoint, and end of the study.
- complete an acceptability questionnaire at the end of the intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will receive probiotic supplement: 1 capsule daily for 2 weeks, followed by 3 capsules daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Intervention | Experimental | Participants will receive probiotic supplement for 4 weeks Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily compliance and stool consistency using the Bristol Stool Form Scale
Participants will record their daily compliance and stool consistency using the Bristol Stool Form Scale. Adherence to the intervention will be evaluated by recording the number of days the probiotic was consumed. To prevent potential non-compliance, participants weill be contacted via telephone on a weekly basis. At the conclusion of the study, participants will be asked to return all empty packaging and any remaining capsules.
Measured: From enrollment to the end of treatment at 4 weeks
Acceptability of the probiotic using an acceptability questionnaire
At the end of the intervention, participants will complete an acceptability questionnaire, including questions regarding ease of use of the probiotic, perceived product safety, and intention to recommend it to others.
Measured: Immediately after the intervention
Secondary outcomes (4)
Effect of Smile Probio 45B on gastrointestinal symptoms
Participants will complete a weekly symptom assessment questionnaire at baseline and at the end of each week of the intervention. The questionnaire will include questions on how frequently they experienced skin reactions, headaches, changes in bowel movement frequency, nausea, diarrhea, constipation, abdominal bloating, abdominal pain, flatulence, acidic taste, and sleep difficulties. Responses will be recorded on a Likert scale (not at all = 1, rarely = 2, occasionally = 3, often = 4, and daily = 5). Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 4 weeks
Effect of Smile Probio 45B on fatigue levels
Fatigue levels will be assessed using the Chalder Fatigue Scale (CFS), which consists of 11 Likert-scale questions designed to distinguish between physical and mental fatigue. Responses will be scored using the Likert method (0-3), yielding a total fatigue score ranging from 0 to 33, with higher scores indicating greater fatigue severity.
Permission for the use of this questionnaire was requested and obtained from the respective creator.
Measured: From enrollment to the end of treatment at 4 weeks
Effect of Smile Probio 45B on quality of life using the EQ-5D-5L questionnaire
Quality of life (QoL) will be assessed using EQ-5D-5L, a standardized instrument for measuring generic health status, comprising five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS). The EQ-5D-5L index score will be calculated using the validated country-specific value set, converting health states into a single index value ranging from 0 to 1, where higher values indicate better health-related quality of life.
Measured: From enrollment to the end of treatment at 4 weeks
Effect of Smile Probio 45B on quality of life using the WHOQOL-BREF questionnaire
Quality of life (QoL) will be assessed using the WHOQOL-BREF (World Health Organization Quality of Life-Abbreviated version), which consists of 26 items rated on a 5-point Likert scale and evaluates four domains: physical health, psychological health, social relationships, and environment, along with two items assessing overall quality of life and general health. Domain scores will be calculated and transformed to a 0-100 scale according to World Health Organization guidelines, with higher scores indicating better quality of life.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start19 May 2025
- Primary completion30 Dec 2025
- Study completion30 Mar 2026
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.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaios Svolos, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362251
- Sponsor's protocol ID
- 25 / 28.03.2025
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study
- ClinicalTrials.gov ID
- NCT07362251
- Acronym / sponsor ID
- 25 / 28.03.2025
- Conditions
- Healthy
- Keywords
- acceptability, probiotic, multi strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 23 Jan 2026 (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 goal of this clinical trial is to examine the compliance and acceptability of the probiotic Smile Probio 45B in healthy adults, as well as its effect on gastrointestinal symptoms, fatigue levels, and quality of life.
Specifically, the study examines the effect of probiotic intake on improving health-related quality of life, reducing self-reported gastrointestinal symptoms such as bloating, as well as regulating stool consistency and frequency. In addition, its impact on participants' self-reported energy levels is investigated, with a particular emphasis on reducing fatigue symptoms.
Participants will:
- take 1 capsule daily (with a main meal) during the first and second week of the intervention, and 3 capsules daily (after each main meal) during the third and fourth week of the intervention, for a total duration of 30 days.
- complete a three-day food record on a weekly basis.
- record their daily bowel habits, including the number of bowel movements and their consistency/form, according to the Bristol Stool Chart, which will be provided to them.
- complete questionnaires assessing health-related quality of life [WHOQOL-BREF (World Health Organization Quality of Life)],a health status questionnaire [EQ-5D (EuroQol-5D)] and a questionnaire evaluating energy levels and fatigue [Chalder Fatigue Scale (CFQ)].
- complete, at baseline and at the end of each intervention week a weekly symptom assessment questionnaire.
- undergo body composition assessment at the beginning, midpoint, and end of the study.
- complete an acceptability questionnaire at the end of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic Intervention | Experimental | Dietary Supplement: ProbioticParticipants will receive probiotic supplement for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged over 18 years
- Body Mass Index (BMI) >18 kg/m² and <30 kg/m²
- No use of antibiotics in the past month
- Willingness to provide informed consent
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding
- Age under 18 years
- Diagnosis of a chronic autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis)
- Diagnosis of type I or II diabetes
- Current use of immunosuppressive medications
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 |
|---|---|---|
| ProbioticParticipants will receive probiotic supplement: 1 capsule daily for 2 weeks, followed by 3 capsules daily for 2 weeks. | Dietary supplement | Probiotic Intervention |
Primary outcome
Daily compliance and stool consistency using the Bristol Stool Form Scale
Time frame: From enrollment to the end of treatment at 4 weeks
Participants will record their daily compliance and stool consistency using the Bristol Stool Form Scale. Adherence to the intervention will be evaluated by recording the number of days the probiotic was consumed. To prevent potential non-compliance, participants weill be contacted via telephone on a weekly basis. At the conclusion of the study, participants will be asked to return all empty packaging and any remaining capsules.
Acceptability of the probiotic using an acceptability questionnaire
Time frame: Immediately after the intervention
At the end of the intervention, participants will complete an acceptability questionnaire, including questions regarding ease of use of the probiotic, perceived product safety, and intention to recommend it to others.
4 secondary outcomes
Effect of Smile Probio 45B on gastrointestinal symptoms
Time frame: From enrollment to the end of treatment at 4 weeks
Effect of Smile Probio 45B on fatigue levels
Time frame: From enrollment to the end of treatment at 4 weeks
Effect of Smile Probio 45B on quality of life using the EQ-5D-5L questionnaire
Time frame: From enrollment to the end of treatment at 4 weeks
Effect of Smile Probio 45B on quality of life using the WHOQOL-BREF questionnaire
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy, run by University of Thessaly at 1 site in Greece.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 1 Sep 2026. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily compliance and stool consistency using the Bristol Stool Form Scale (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. 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 1 Sep 2026.