120
Participants
Start Date
July 16, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Amoxicillin + Saccharomyces boulardii CNCM I-745
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
Amoxicillin + Placebo
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
Stool samples
"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)"
BSFS : Bristol Stool Form Scale
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.
GSRS : Gastrointestinal Symptom Rating Scale
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).
RECRUITING
University Medical Centre Ljubljana, Ljubljana
Lead Sponsor
Biocodex
INDUSTRY