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)).
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.
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,
Parallel
Amoxicillin + Saccharomyces boulardii CNCM I-745
DrugAt inclusion visit (V1), the Investigator will dispense and ask the subject to take Amoxicillin 1000 mg bid for 14 days + Saccharomyces boulardii 250 mg x 2 twice a day for 21 days
Amoxicillin + Placebo
DrugAt inclusion visit (V1),the Investigator will dispense and ask the subject to take Amoxicillin 1000 mg bid for 14 days + a matching placebo bid for 21 days
Stool samples
Other interventionThe subject will be asked to collect thanks to four OMNIgene® •GUT OMR-200 kits : * an initial stool collection when returning home at D1 (in any case before any intake of amoxicillin and of the investigational medication and up to 1 day after D1). * a stool collection at home after the phone call 1, Day 7 (stool collection up to Day 7 + 1 day) * a stool collection at home after the phone call 2, Day 14 (stool collection up to Day 14 + 1 day) * at home the day of the Visit 2, Day 21 (stool collection up to Day 21 + 1 day)
BSFS : Bristol Stool Form Scale
Other interventionAll included subjects will have to complete a stool diary BSFS (Bristol Stool Form Scale) daily and at each bowel movement, from Day 1 until the end of study treatment (Day 21). The patient will fill the form with the date, the time, and the stool texture.
GSRS : Gastrointestinal Symptom Rating Scale
Other interventionAll included subjects will have to complete a GSRS (Gastrointestinal Symptom Response Score) questionnaire weekly from Day 1 until the end of the study treatment (Day 21).
Assessment of the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gut microbiota of patients receiving antibiotic
Primary endpoint : analysis of the intestinal microbiota in the patient's stools
Assessment of the efficacy of Saccharomyces boulardii CNCM I-745 in prevention of antibiotic-associated diarrhoea (AAD) in patients undergoing antibiotic therapy
Secondary efficacy endpoint : Incidence of AAD (The number of AAD episodes that occurred during the treatment period) will be assessed using the Bristol Stool Form Scale (BSFS) recorded daily.
Assessment of the efficacy of Saccharomyces boulardii CNCM I-745 on the stools in patients undergoing antibiotic therapy : Recorded stools in the Bristol Stool Form Scale (BSFS)
Secondary efficacy endpoint : Time frame in hours up to the time of the last liquid or loose stool (defined as types 6 or 7 on Bristol Stool Form Scale (BSFS)) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), as recorded by the patients in the stool diary or as collected by the investigator
Assess the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gastro-intestinal symptoms of patients receiving antibiotic therapy : Changes from baseline of the GSRS
Secondary efficacy endpoint : Changes from baseline of the Gastrointestinal Symptom Rating Scale (GSRS) score (total score) and diarrhea sub-scores will be compared weekly between the treatment groups. The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Recording adverse events
Safety endpoint : Recorded adverse events (number of events and number of participants with at least one event), vital signs, and physical examination
Assess the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the specific gastro-intestinal symptoms of patients receiving antibiotic therapy : Gastrointestinal Symptom Rating scale (GSRS)
Exploratory endpoint : Changes from baseline of the GSRS subscores (except diarrhea) will be compared weekly between the treatment groups.The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
Assess the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gut resistome of patients receiving antibiotic : Changes on the fecal Antimicrobial Resistance Genes (ARGs)
Exploratory endpoint : Changes observed on the gut resistome, abundance and diversity of the fecal ARGs will be analysed by treatment group and at each assessment time.
