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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Thessaly

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • One sachet of the probiotic daily
  • Two sachets of the probiotic daily

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators