Antibiotic TherapyVivomixx neo®NCT07380009
Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx Neo® 460 in Adults Receiving Antibiotic Therapy.
A study testing One sachet of the probiotic daily and Two sachets of the probiotic daily in people with Antibiotic Therapy, run by University of Thessaly at 1 site in Greece.
Trial summary
This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx Neo® 460 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Therapy
- What is being tested?
- One sachet of the probiotic daily and Two sachets of the probiotic daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 12 Dec 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Initiation of oral antibiotic therapy lasting more than 3 days
- History of diarrhea during previous antibiotic treatment
- Eligible antibiotics include: (a) amoxicillin with clavulanic acid, (b) clindamycin, and (c) second- or third-generation cephalosporins
- Willingness to provide informed consent to participate in the study
Who cannot join
- 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 type II diabetes
- Renal or hepatic disease
- Current use of immunosuppressive medications
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- Current use of other supplements, probiotics, prebiotics, or synbiotics
- Use of antibiotics within the past month
- Use of laxatives or antidiarrheal medications within the past 2 weeks
- Pre-existing diarrhea within the past 2 weeks
- 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 past 6 months
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Physical Education, Sport Science and Dietetics
Trikala, 42132
About this study
Official title: Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx Neo® 460 in Adults Receiving Antibiotic Therapy: a Randomized, Open-label Clinical Trial.
This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx Neo® 460 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.
- Conditions
- Antibiotic Therapy
- Being tested
- One sachet of the probiotic daily, Two sachets of the probiotic daily
- Keywords
- antibiotic, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One sachet of the probiotic dailyDietary supplement
Twenty participants will receive one sachet of the probiotic daily.
Two sachets of the probiotic dailyDietary supplement
Twenty participants will receive two sachets of the probiotic daily.
| Study group | Role | What they receive |
|---|---|---|
| One sachet of the probiotic daily | Other | Twenty participants will receive one sachet of the probiotic daily. Receives: Dietary Supplement: One sachet of the probiotic daily |
| Two sachets of the probiotic daily | Other | Twenty participants will receive two sachets of the probiotic daily. Receives: Dietary Supplement: Two sachets of the probiotic daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Participants will be required to complete a daily Compliance Form. To minimize potential non-compliance with form completion, weekly telephone follow-up will be conducted.
- The number of participants who complete the study and those who withdraw will be recorded.
- When available, reasons for withdrawal will be analyzed to better understand participant responses to the intervention.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 17 days maximum
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start12 Dec 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic TherapyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaios Svolos, University of Thessaly
- Investigators
- ODYSSEAS ANDROUTSOS, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380009
- Sponsor's protocol ID
- 103 / 01.08.2025
- Acronym
- Vivomixx neo®
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx Neo® 460 in Adults Receiving Antibiotic Therapy: a Randomized, Open-label Clinical Trial.
- ClinicalTrials.gov ID
- NCT07380009
- Acronym / sponsor ID
- Vivomixx neo® / 103 / 01.08.2025
- Conditions
- Antibiotic Therapy
- Keywords
- antibiotic, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx Neo® 460 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One sachet of the probiotic daily | Other | Dietary Supplement: One sachet of the probiotic dailyTwenty participants will receive one sachet of the probiotic daily. |
| Two sachets of the probiotic daily | Other | Dietary Supplement: Two sachets of the probiotic dailyTwenty participants will receive two sachets of the probiotic daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged over 18 years
- Initiation of oral antibiotic therapy lasting more than 3 days
- History of diarrhea during previous antibiotic treatment
- Eligible antibiotics include: (a) amoxicillin with clavulanic acid, (b) clindamycin, and (c) second- or third-generation cephalosporins
- Willingness to provide informed consent to participate in the study
Key exclusion criteria (13 listed)
- 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 type II diabetes
- Renal or hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One sachet of the probiotic dailyTwenty participants will receive one sachet of the probiotic daily. | Dietary supplement | One sachet of the probiotic daily |
| Two sachets of the probiotic dailyTwenty participants will receive two sachets of the probiotic daily. | Dietary supplement | Two sachets of the probiotic daily |
Primary outcome
Adherence to the probiotic using a daily Compliance Form
Time frame: From enrollment to the end of treatment at 17 days maximum
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 * Participants will be required to complete a daily Compliance Form. To minimize potential non-compliance with form completion, weekly telephone follow-up will be conducted. * The number of participants who complete the study and those who withdraw will be recorded. * When available, reasons for withdrawal will be analyzed to better understand participant responses to the intervention.
Acceptability of the probiotic supplement using an acceptability questionnaire
Time frame: 2 weeks (immediately after completion of the 2-week intervention)
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.
Daily assessment of stool type using the Bristol Stool Form Scale
Time frame: From enrollment to the end of treatment at 17 days maximum
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.
3 secondary outcomes
Effect of the probiotic on fatigue levels
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ODYSSEAS ANDROUTSOS principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One sachet of the probiotic daily and Two sachets of the probiotic daily in people with Antibiotic Therapy, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the probiotic using a daily Compliance Form (time frame: From enrollment to the end of treatment at 17 days maximum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.