Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx® 460 Neo 9 in Adults Receiving Antibiotic Therapy. (VIVOMIXX 460)

January 23, 2026 updated by: Vaios Svolos, University of Thessaly

Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx® 460 Neo 9 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® 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Trikala, Greece, 42132
        • Recruiting
        • School of Physical Education, Sport Science and Dietetics
        • Contact:
          • School of Physical Education, Sport Science and Dietetics
          • Phone Number: +30 24310 23602
          • Email: g-dnd@uth.gr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: One sachet of the probiotic daily
Twenty participants will receive one sachet of the probiotic daily.
Dietary supplement: One sachet of the probiotic daily
Twenty participants will receive one sachet of the probiotic daily.
Other: Two sachets of the probiotic daily
Twenty participants will receive two sachets of the probiotic daily.
Dietary supplement: Two sachets of the probiotic daily
Twenty participants will receive two sachets of the probiotic daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 17 days maximum
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.
2 weeks (immediately after completion of the 2-week intervention)
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.
From enrollment to the end of treatment at 17 days maximum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the probiotic on fatigue levels
Time Frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
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.
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)
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
Time Frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 103 / 01.08.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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