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)) (SUBLYME)

NCT06451913 Phase 4 RECRUITING

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)).

Details

Lead sponsor	Biocodex
Phase	Phase 4
Status	RECRUITING
Enrolment	120
Start date	2025-07-16
Completion	2026-12

Conditions

• Erythema Migrans of Lyme Disease

Interventions

• Amoxicillin + Saccharomyces boulardii CNCM I-745
• Amoxicillin + Placebo
• Stool samples
• BSFS : Bristol Stool Form Scale
• GSRS : Gastrointestinal Symptom Rating Scale

Primary outcomes

• Assessment of the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gut microbiota of patients receiving antibiotic — At Day 1, Day 7, Day 14 and Day 21
  Primary endpoint : analysis of the intestinal microbiota in the patient's stools

Countries

Slovenia