Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07380009

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

Led by University of Thessaly · Updated on 2026-02-02

40

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged over 18 years
  • Starting oral antibiotic therapy lasting more than 3 days
  • History of diarrhea during previous antibiotic treatment
  • Eligible antibiotics include amoxicillin with clavulanic acid, clindamycin, or second- or third-generation cephalosporins
  • Willingness to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

School of Physical Education, Sport Science and Dietetics

Trikala, Greece, 42132

Actively Recruiting

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Research Team

V

VAIOS SVOLOS, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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