Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study
Overview
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.
Interventions
- Dietary supplement Probiotic
Participants will receive probiotic supplement: 1 capsule daily for 2 weeks, followed by 3 capsules daily for 2 weeks.
Primary outcome measures
- Daily compliance and stool consistency using the Bristol Stool Form Scale [Time frame: From enrollment to the end of treatment at 4 weeks]
- Acceptability of the probiotic using an acceptability questionnaire [Time frame: Immediately after the intervention]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Greece · 1 center
- School of Physical Education, Sport Science and Dietetics — Trikala
Identifiers
NCT: NCT07362251 · 25 / 28.03.2025