Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults

Recruiting now · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT07362251

Run by

University of Thessaly

People needed

40

Starts

2025-05-19

Expected to finish

2026-03-30

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• School of Physical Education, Sport Science and Dietetics — Trikala, Thessaly, Greece (enrolling)

Full record on ClinicalTrials.gov

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