About this trial
The aim of this study is to assess the effect of Saccharomyces boulardii CNCM I-745 on gut microbiota in patients undergoing antibiotic therapy (in the context of erythema migrans (early skin form of Lyme borreliosis)).
Eligibility criteria
Qualifiers
Adult Patients, ≥18 years old.
Who are prescribed antibiotic therapy (as per medical routine practices, amoxicillin 1000 mg bid for 14 days) in the context of erythema migrans (early skin form of Lyme borreliosis).
Able to comply with study requirements and to provide signed informed consent before any study procedure.
Has no condition that may interfere with the study assessments.
Disqualifiers
History of hypersensitivity to the study treatments (active substance or excipients), brewer's or baker's yeast,
Contraindication and special warning to the study drugs according to the SmPCs,
History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average,
History of chronic or recurrent diarrhoea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily,
Trial design
Treatments tested in this trial
- Amoxicillin + Saccharomyces boulardii CNCM I-745
- Amoxicillin + Placebo
- Stool samples
- BSFS : Bristol Stool Form Scale
- GSRS : Gastrointestinal Symptom Rating Scale