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

NCT07380009 | Recruiting DMC

• 1 other identifier: 103 / 01.08.2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antibiotic Therapy

Keywords

antibiotic; probiotic; vivomixx

Outcome Measures

Primary Outcomes (3)

• 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.

  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

Secondary Outcomes (3)

• Effect of the probiotic on fatigue levels

  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

  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

  Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

Study Arms (2)

One sachet of the probiotic daily

OTHER

Twenty participants will receive one sachet of the probiotic daily.

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.

Dietary Supplement: Two sachets of the probiotic daily

Interventions

One sachet of the probiotic daily DIETARY_SUPPLEMENT

Twenty participants will receive one sachet of the probiotic daily.

One sachet of the probiotic daily

Two sachets of the probiotic daily DIETARY_SUPPLEMENT

Twenty participants will receive two sachets of the probiotic daily.

Two sachets of the probiotic daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

School of Physical Education, Sport Science and Dietetics

Trikala, 42132, Greece

RECRUITING

Study Officials

• 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

Central Study Contacts

VAIOS SVOLOS, PhD

CONTACT

+30 6989953903; vaiossvolos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian, Postdoctoral Researcher

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 2, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)