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