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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Intervention | Experimental | Participants will receive probiotic supplement for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Participants will receive probiotic supplement: 1 capsule daily for 2 weeks, followed by 3 capsules daily for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Smile Probio 45B on gastrointestinal symptoms | Participants will complete a weekly symptom assessment questionnaire at baseline and at the end of each week of the intervention. The questionnaire will include questions on how frequently they experienced skin reactions, headaches, changes in bowel movement frequency, nausea, diarrhea, constipation, abdominal bloating, abdominal pain, flatulence, acidic taste, and sleep difficulties. Responses will be recorded on a Likert scale (not at all = 1, rarely = 2, occasionally = 3, often = 4, and daily = 5). Higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VAIOS SVOLOS, PhD | Contact | +30 6989953903 | vaiossvolos@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Physical Education, Sport Science and Dietetics | Recruiting | Trikala | Thessaly | 42132 | Greece |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| From enrollment to the end of treatment at 4 weeks |
| Effect of Smile Probio 45B on fatigue levels | Fatigue levels will be assessed using the Chalder Fatigue Scale (CFS), which consists of 11 Likert-scale questions designed to distinguish between physical and mental fatigue. Responses will be scored using the Likert method (0-3), yielding a total fatigue score ranging from 0 to 33, with higher scores indicating greater fatigue severity. Permission for the use of this questionnaire was requested and obtained from the respective creator. | 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 | Quality of life (QoL) will be assessed using EQ-5D-5L, a standardized instrument for measuring generic health status, comprising five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS). The EQ-5D-5L index score will be calculated using the validated country-specific value set, converting health states into a single index value ranging from 0 to 1, where higher values indicate better health-related quality of life. | From enrollment to the end of treatment at 4 weeks |
| Effect of Smile Probio 45B on quality of life using the WHOQOL-BREF questionnaire | Quality of life (QoL) will be assessed using the WHOQOL-BREF (World Health Organization Quality of Life-Abbreviated version), which consists of 26 items rated on a 5-point Likert scale and evaluates four domains: physical health, psychological health, social relationships, and environment, along with two items assessing overall quality of life and general health. Domain scores will be calculated and transformed to a 0-100 scale according to World Health Organization guidelines, with higher scores indicating better quality of life. | From enrollment to the end of treatment at 4 weeks |
| D019602 |
| Food and Beverages |