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

NCT07362251 | Recruiting

• 1 other identifier: 25 / 28.03.2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Keywords

acceptability; probiotic; multi strain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately after the intervention

Secondary Outcomes (4)

• Effect of Smile Probio 45B on gastrointestinal symptoms

  From enrollment to the end of treatment at 4 weeks

• Effect of Smile Probio 45B on fatigue levels

  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

  From enrollment to the end of treatment at 4 weeks

• Effect of Smile Probio 45B on quality of life using the WHOQOL-BREF questionnaire

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Probiotic Intervention

EXPERIMENTAL

Participants will receive probiotic supplement for 4 weeks

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants will receive probiotic supplement: 1 capsule daily for 2 weeks, followed by 3 capsules daily for 2 weeks.

Probiotic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

School of Physical Education, Sport Science and Dietetics

Trikala, Thessaly, 42132, Greece

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

VAIOS SVOLOS, PhD

CONTACT

+30 6989953903; vaiossvolos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian, Postdoctoral Researcher

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 23, 2026
• Study Start: May 19, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)