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

University of Thessaly

Status

Enrolling

Conditions

Healthy

Treatments

Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT07362251

25 / 28.03.2025

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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