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This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx® 460 Neo 9 when administered concurrently with antibiotic therapy. Participants are randomized to receive one of two dosing regimens: a low daily dose or a high daily dose. The study will assess the effects of these regimens on the prevention of antibiotic-associated diarrhea (AAD), gastrointestinal symptoms, and patient adherence and acceptability. The results are intended to provide evidence to optimize the clinical use of probiotics alongside antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One sachet of the probiotic daily | Other | Twenty participants will receive one sachet of the probiotic daily. |
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| Two sachets of the probiotic daily | Other | Twenty participants will receive two sachets of the probiotic daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One sachet of the probiotic daily | Dietary Supplement | Twenty participants will receive one sachet of the probiotic daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the probiotic using a daily Compliance Form | Adherence will be assessed by recording the number of days participants took the supplement and the amount consumed, as well as by considering participant drop-out rates. Methods of measurement
| From enrollment to the end of treatment at 17 days maximum |
| Acceptability of the probiotic supplement using an acceptability questionnaire | Acceptability will be assessed by evaluating participants' perceptions of the intervention procedures and the administered supplement in terms of ease of use, palatability, safety, and compatibility with daily life. Acceptability will be measured using a structured acceptability questionnaire completed at the end of the intervention. The questionnaire will include items assessing ease of intake, difficulties in integrating the supplement into daily routines, perceived safety, overall study experience, and intention to continue product use. Responses will be recorded using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), allowing quantitative analysis. | 2 weeks (immediately after completion of the 2-week intervention) |
| Daily assessment of stool type using the Bristol Stool Form Scale | Changes in bowel habits will be assessed by daily recording of bowel movements throughout the intervention period. Participants will document the frequency of bowel movements and stool type using the Bristol Stool Form Scale. Numbers 6,7 in the Bristol Stool Form are associated with diarrhea. | From enrollment to the end of treatment at 17 days maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the probiotic on fatigue levels | Participants will complete the Chalder Fatigue Scale (CFQ) questionnaire at the start and at the end of the intervention. Questionnaire 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. |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| ODYSSEAS ANDROUTSOS | Lab of Clinical Nutrition and Dietetics, Department of Nutrition and Dietetics, School of Physical Education, Sports Science and Dietetics, University of Thessaly, 42100 Trikala, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Physical Education, Sport Science and Dietetics | Recruiting | Trikala | 42132 | Greece |
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| Two sachets of the probiotic daily | Dietary Supplement | Twenty participants will receive two sachets of the probiotic daily. |
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| Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention) |
| Effect of the intervention on participants' self-reported quality of life by WHOQOL-BREF questionnaire | Participants will complete health-related quality of life questionnaire [WHOQOL-BREF (World Health Organization Quality of Life)], 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. | Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention) |
| Effect of the intervention on participants' self-reported quality of life by 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. | Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention) |