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Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx® 460 Neo 9 in Adults Receiving Antibiotic Therapy: a Randomized, Open-label Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
School of Physical Education, Sport Science and Dietetics
RECRUITING
Trikala
Contact Information
Primary
VAIOS SVOLOS, PhD
vaiossvolos@gmail.com
+30 6989953903
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 40
Treatments
Other: One sachet of the probiotic daily
Twenty participants will receive one sachet of the probiotic daily.
Other: Two sachets of the probiotic daily
Twenty participants will receive two sachets of the probiotic daily.
Related Therapeutic Areas
Sponsors
Leads: University of Thessaly

This content was sourced from clinicaltrials.gov