SACCHAROMYCES BOULARDII CNCM I-745 (lyophilized) for Erythema migrans (early Lyme borreliosis) | Antibiotic therapy

Inclusion criteria

• {"criterion_text":"-Adult Patients, ≥18 years old"}
• {"criterion_text":"-Who were 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)."}
• {"criterion_text":"-Able to comply with study requirements and to provide signed informed consent before any study procedure."}
• {"criterion_text":"-Has no condition that may interfere with the study assessments."}
• {"criterion_text":"-Able to fulfil in the diary stool log, according to the physician’s opinion."}
• {"criterion_text":"-Regular defecation (frequency and stool consistency, with at least about three bowel movements a week)."}
• {"criterion_text":"-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

• {"criterion_text":"-History of hypersensitivity to the study treatments (active substance or excipients), brewer’s or baker’s yeast"}
• {"criterion_text":"-Contraindication and special warning to the study drugs according to the SmPCs"}
• {"criterion_text":"-History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average"}
• {"criterion_text":"-History of chronic or recurrent diarrhoea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily"}
• {"criterion_text":"-Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago)"}
• {"criterion_text":"-History of Clostridium difficile infection"}
• {"criterion_text":"-Active gastrointestinal inflammatory disease"}
• {"criterion_text":"-Known chronic or recurrent systemic disorder that may interfere with the study drug evaluation"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Contraindication and special warning to the study drugs according to the SmPCs"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Systemic antibacterial therapy during the 2 months prior to study enrollment"}
• {"criterion_text":"-New prescription medications during the 2 weeks prior to study enrollment"}
• {"criterion_text":"-AUse 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, during 4 weeks prior to study enrollment and during the study"}
• {"criterion_text":"-Intake of antifungals within 14 days prior to study enrollment"}
• {"criterion_text":"-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"}
• {"criterion_text":"-History or presence of drug or alcohol abuse"}
• {"criterion_text":"-Heavy smoker (more than 10 cigarettes per day)"}
• {"criterion_text":"-Breast-feeding woman"}
• {"criterion_text":"-Patients enrolled in another interventional clinical trial where they received an investigation treatment within the past 30 days"}

Primary endpoints

• {"endpoint_text":"-Changes observed: -\tin bacterial and fungal taxonomy (alpha diversity, Shanon index) -\t in beta diversity metrics (such as Bray Curtis dissimilarity, Jaccard distance, Unifrac...). Analyses will be performed by treatment group and at each assessment time.","definition_or_measurement_approach":"Assessment of bacterial and fungal taxonomy changes using alpha diversity (Shannon index) and beta diversity metrics (Bray Curtis dissimilarity, Jaccard distance, UniFrac). Analyses performed by treatment group and at each assessment time."}

Secondary endpoints

• {"endpoint_text":"-Incidence of AAD (The number of AAD episodes that occurred during the treatment period) will be assessed using the Bristol Stool Form Scale (BSFS) recorded daily. Analyses will be performed by treatment group","definition_or_measurement_approach":"Incidence of antibiotic-associated diarrhoea (AAD) measured as number of AAD episodes during treatment, assessed daily using the Bristol Stool Form Scale (BSFS); analyses by treatment group."}
• {"endpoint_text":"-The proportion of patients with at least one AAD episode will be compared between the two treatment groups","definition_or_measurement_approach":"Proportion of patients experiencing ≥1 AAD episode during study compared between treatment groups (based on BSFS/stool diary)."}
• {"endpoint_text":"-Time frame in hours up to the time of the last liquid or loose stool (defined as types 6 or 7 on BSFS) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), as recorded by the patients in the stool diary or as collected by the investigator, the average number of stools per week, the average number of unformed or formed (according to the score) stools per week, duration of number of days with diarrhea, number of episodes of diarrhea.","definition_or_measurement_approach":"Time to last liquid/loose stool (BSFS types 6 or 7) followed by 24-h period with improved stool consistency; average stools/week; average unformed/formed stools/week; duration in days with diarrhea; number of diarrhea episodes—based on patient stool diary and investigator records."}
• {"endpoint_text":"-Changes from baseline of the GSRS score (total score) and diarrhea sub-scores will be compared weekly between the treatment groups.","definition_or_measurement_approach":"Weekly comparison of change from baseline in GSRS total score and diarrhea sub-scores between groups."}
• {"endpoint_text":"-Safety will be evaluated based on recorded adverse events (number of events and number of participants with at least one event), vital signs, and physical examination (quantitative statistics at each assessment time and changes from baseline).","definition_or_measurement_approach":"Safety assessed by recorded adverse events (counts and participants with ≥1 event), vital signs, and physical examinations with quantitative summaries at each assessment and changes from baseline."}

Slovenia

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

29-03-2024

Processing Time Days

30

Number Of Sites

1

Number Of Participants

20

Czechia

Earliest CTIS Part Ii Submission Date

17-06-2025

Latest Decision Or Authorization Date

16-07-2025

Processing Time Days

29

Number Of Sites

9

Number Of Participants

60

Lithuania

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

16-07-2025

Processing Time Days

23

Number Of Sites

3

Number Of Participants

20

Slovakia

Earliest CTIS Part Ii Submission Date

07-07-2025

Latest Decision Or Authorization Date

16-07-2025

Processing Time Days

9

Number Of Sites

5

Number Of Participants

20

Primary sponsor

Full Name

Biocodex

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Scope International AG

Responsibilities

Clinical Research Organization

Third parties

• {"country":"Germany","full_name":"CeGaT GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Atlanstat","duties_or_roles":"codes:6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Clinical Microbiomics, Symbion","duties_or_roles":"code:4","organisation_type":"Health care"}
• {"country":"Germany","full_name":"Scope International AG","duties_or_roles":"Clinical Research Organization","organisation_type":"Pharmaceutical company"}