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)).
The study is designed to compare the efficacy of Saccharomyces boulardii CNCM-I-745 500 mg bid to a placebo in patients undergoing antibiotic therapy in the context of erythema migrans as the early form of Lyme borreliosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
120
At 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
At 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
The 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)
University Medical Centre Ljubljana
Ljubljana, Slovenia
RECRUITINGAssessment 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
Time frame: At Day 1, Day 7, Day 14 and Day 21
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.
Time frame: At Day 1, Day 7, Day 14 and Day 21
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
Time frame: At Day 1, Day 7, Day 14 and Day 21
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.
Time frame: Weekly from Day 1 to Day 21
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All 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.
All 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).