Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:32 PM
Study NCT ID:
NCT07362251
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults
Sponsor:
University of Thessaly
Organization:
Study Overview
Official Title:
Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: