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))

NCT ID: NCT06451913

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Amoxicillin + Saccharomyces boulardii CNCM I-745

The patients will received oral Amoxicillin (1000 mg capsules bid) for 14 days and oral Saccharomyces boulardii CNCM I-745 (®) 250 mg x 2 capsules twice a day for 21 days.

Group Type: EXPERIMENTAL

Amoxicillin + Saccharomyces boulardii CNCM I-745

Intervention Type: DRUG

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

Stool samples

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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).

Amoxicillin + Placebo

The patients will received oral Amoxicillin (1000 mg capsules bid) for 14 days + oral Placebo capsules for 21 days.

Group Type: PLACEBO_COMPARATOR

Amoxicillin + Placebo

Intervention Type: DRUG

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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).

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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)

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult Patients, ≥18 years old.
• Who are prescribed antibiotic therapy (as per medical routine practices, amoxicillin 1000 mg bid for 14 days) in the context of erythema migrans (early skin form of Lyme borreliosis).
• Able to comply with study requirements and to provide signed informed consent before any study procedure.
• Has no condition that may interfere with the study assessments.
• Able to fulfil in the diary stool log, according to the physician's opinion.
• Regular defecation (frequency and stool consistency, with at least about three bowel movements a week).
• For women of childbearing potential:
• A negative urine pregnancy test immediately prior to starting the study treatment,
• Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more acceptable methods of contraception that should be maintained throughout the study.

Exclusion Criteria

• History of hypersensitivity to the study treatments (active substance or excipients), brewer's or baker's yeast,
• Contraindication and special warning to the study drugs according to the SmPCs,
• History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average,
• History of chronic or recurrent diarrhoea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily,
• Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago),
• History of Clostridium difficile infection,
• Active gastrointestinal inflammatory disease,
• Known chronic or recurrent systemic disorder that may interfere with the study drug evaluation,
• Immunocompromised (organtransplants, leukaemia, malignant tumours, radiotherapy, chemotherapy,prolonged high dose cortisone treatment, immunosuppressant treament) or critically ill patients (such as autoimmune disease, HIV,…), patients with a central venous catheter,
• Severe hepatic or renal impairment,
• Systemic antibacterial therapy during the 2 months prior to study enrollment,
• New prescription medications during the 2 weeks prior to study enrollment,
• Use of any drug or product that alters gut microbiota or function, such as probiotics, laxatives, antiemetics, cisapride, antisecretory or adsorbent treatments (racecadotril, smectite, activated charcoal), opiates such as loperamide, atropine and other cholinergic agents, 4 weeks prior to study enrollment and during the study,
• Intake of antifungals within 14 days prior to study enrollment,
• Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, and during the study as assessed by the Investigator,
• History or presence of drug or alcohol abuse,
• Heavy smoker (more than 10 cigarettes per day),
• Breast-feeding woman,
• Patients enrolled in another interventional clinical trial where they received an investigation treatment within the past 30 days,
• Any condition or personal circumstance that, in the opinion of the investigator, rendered the subject unlikely or unable to comply with the full study protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocodex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oana BERNARD, MD

Role: STUDY_DIRECTOR

Chief Scientific Officer

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Gaëlle MARIAULE

Role: CONTACT

g.mariaule@biocodex.fr

03.44.86.82.28 ext. +33

Carine FRANCOIS

Role: CONTACT

c.francois@biocodex.fr

03.44.86.82.28 ext. z+33

Facility Contacts

Martina Jaklič, PhD

Role: primary

martina.jaklic@kclj.si

+386 1 522 2037

Other Identifiers

2023-508694-80-01

Identifier Type: CTIS

Identifier Source: secondary_id

SUBLYME - Sb 241

Identifier Type: -

Identifier Source: org_study_id