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Recruiting Phase 4 NCT06451913

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))

Trial Parameters

Condition Erythema Migrans of Lyme Disease
Sponsor Biocodex
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-16
Completion 2026-12
Interventions
Amoxicillin + Saccharomyces boulardii CNCM I-745Amoxicillin + PlaceboStool samples

Brief Summary

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

Inclusion Criteria: * 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. * Able to fulfil in the diary stool log, according to the physician's opinion. * Regular defecation (frequency and stool consistency, with at least about three bowel movements a week). * For women of childbearing potential: * A negative urine pregnancy test immediately prior to starting the study treatment, * Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant,

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