Acceptability of the Smile Probio 45B multi-strain probiotic in healthy adults
Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study
This 30-day test gives healthy adults Smile Probio 45B to see if people can follow the dosing and whether it changes digestion, stool habits, energy, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Trikala, Thessaly) |
| Trial ID | NCT07362251 on ClinicalTrials.gov |
What this trial studies
Healthy adults with BMI between 18 and 30 and no recent antibiotic or probiotic use will take Smile Probio 45B for 30 days with stepped dosing (1 capsule daily for weeks 1–2, 3 capsules daily for weeks 3–4). Participants will keep weekly three-day food records and daily logs of bowel movements and stool form to measure compliance and acceptability. Self-reported gastrointestinal symptoms, fatigue/energy levels, and health-related quality of life will be recorded before and after the intervention. People who are pregnant, breastfeeding, taking antibiotics or immunosuppressants, or with certain chronic diseases are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with BMI 18–30 who are not pregnant or breastfeeding, have not used antibiotics or probiotics recently, and can attend the site in Trikala, Thessaly.
Not a fit: People with chronic autoimmune disease, diabetes, recent gastrointestinal surgery, current antibiotic or immunosuppressive use, pregnancy, or breastfeeding are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If acceptable and adhered to, the probiotic could reduce minor gastrointestinal symptoms, normalize stool patterns, and modestly increase self-reported energy and quality of life in healthy adults.
How similar studies have performed: Previous trials of multi-strain probiotics have shown mixed but sometimes positive effects on GI symptoms and stool consistency, though trials focused on acceptability and compliance are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trikala, Thessaly
- School of Physical Education, Sport Science and Dietetics — Trikala, Thessaly, Greece (Recruiting)
Study contacts
- Study coordinator: VAIOS SVOLOS, PhD
- Email: vaiossvolos@gmail.com
- Phone: +30 6989953903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.