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Completed NCT07380009

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

Conditions: Antibiotic Therapy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Thessaly

Location: School of Physical Education, Sport Science and Dietetics Trikala

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07380009). StuddyBuddy aggregates publicly available trial information.