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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))

NCT06451913 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-27

No results posted yet for this study

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)).

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).

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Principal Investigators

  • Oana BERNARD, MD · Chief Scientific Officer

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06451913 on ClinicalTrials.gov