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OpenTrials
Completed

NCT Number: NCT07380009

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

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.

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Key information

Conditions

Antibiotic Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Physical Education, Sport Science and Dietetics

Trikala, 42132, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One sachet of the probiotic daily

Dietary Supplement

Twenty participants will receive one sachet of the probiotic daily.

Two sachets of the probiotic daily

Dietary Supplement

Twenty participants will receive two sachets of the probiotic daily.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study 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.

Acronym: Vivomixx neo®

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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