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))

PHASE4RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 16, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Erythema Migrans of Lyme Disease
Interventions
DRUG

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

DRUG

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

OTHER

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)"

OTHER

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.

OTHER

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).

Trial Locations (1)

1000

RECRUITING

University Medical Centre Ljubljana, Ljubljana

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocodex

INDUSTRY

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)) | Biotech Hunter | Biotech Hunter