Acceptability and adherence to low versus high daily doses of the Vivomixx probiotic during antibiotic treatment
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.
This trial will test whether adults on antibiotics find a low or high daily dose of the probiotic Vivomixx easier to use and whether it helps prevent antibiotic-associated diarrhea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Trikala) |
| Trial ID | NCT07380009 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized interventional study enrolls adults starting oral antibiotics for more than three days and with a prior history of diarrhea on antibiotics. Participants are randomized to one sachet (low dose) or two sachets (high dose) of Vivomixx taken daily alongside their antibiotic course. The study tracks acceptability, adherence, occurrence of antibiotic-associated diarrhea, and other gastrointestinal symptoms during and shortly after antibiotic therapy. Results aim to inform optimal probiotic dosing when given concurrently with specific antibiotics such as amoxicillin-clavulanic acid, clindamycin, and second- or third-generation cephalosporins.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are beginning an oral antibiotic course lasting more than three days (amoxicillin–clavulanic acid, clindamycin, or certain cephalosporins) and who have had diarrhea during prior antibiotic treatment.
Not a fit: Patients who are pregnant or breastfeeding, have chronic autoimmune disease, diabetes, renal or hepatic disease, are on immunosuppressants or other probiotics/prebiotics, recently used antibiotics, or currently have diarrhea are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the study could identify a probiotic dosing schedule that is easier for patients to follow and that reduces antibiotic-associated diarrhea.
How similar studies have performed: Previous randomized trials have shown some probiotics can reduce antibiotic-associated diarrhea, but direct comparisons of patient acceptability and adherence between Vivomixx dosing regimens are relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trikala
- School of Physical Education, Sport Science and Dietetics — Trikala, Greece (Recruiting)
Study contacts
- Principal investigator: Odysseas Androutsos — Lab of Clinical Nutrition and Dietetics, Department of Nutrition and Dietetics, School of Physical Education, Sports Science and Dietetics, University of Thessaly, 42100 Trikala, Greece
- Study coordinator: VAIOS SVOLOS, PhD
- Email: vaiossvolos@gmail.com
- Phone: +30 6989953903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.