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))

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Biocodex · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)).

Detailed description

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.

Conditions

• Erythema Migrans of Lyme Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-07-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-06-11
• Last updated: 2025-08-27

Locations

1 site across 1 country: Slovenia