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RecruitingNot ApplicableNCT07380009

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

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.

Sponsor

University of Thessaly

Enrollment

40 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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

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Interventions

DIETARY_SUPPLEMENTOne sachet of the probiotic daily

Twenty participants will receive one sachet of the probiotic daily.

DIETARY_SUPPLEMENTTwo sachets of the probiotic daily

Twenty participants will receive two sachets of the probiotic daily.

Locations(1)

School of Physical Education, Sport Science and Dietetics

Trikala, Greece

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NCT07380009