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

University of Thessaly

Status: Enrolling

Conditions: Antibiotic Therapy

Treatments: Dietary Supplement: Two sachets of the probiotic daily; Dietary Supplement: One sachet of the probiotic daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07380009

103 / 01.08.2025

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

One sachet of the probiotic daily

Other group

Description:

Twenty participants will receive one sachet of the probiotic daily.

Treatment:

Dietary Supplement: One sachet of the probiotic daily

Two sachets of the probiotic daily

Other group

Description:

Twenty participants will receive two sachets of the probiotic daily.

Treatment:

Dietary Supplement: Two sachets of the probiotic daily