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

Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx Neo® 460 in Adults Receiving Antibiotic Therapy: a Randomized, Open-label Clinical Trial.

This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx Neo® 460 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.

Inclusion Criteria:

• 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 Criteria:

• 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