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