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

NCT07362251 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probiotic

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

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2025-12-30
Completion
2026-03-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362251 on ClinicalTrials.gov