Effect of Saccharomyces Boulardii CNCM I-745 on Gut Microbiota in Patients Undergoing Antibiotic … (NCT06451913) | Clinical Trial Compass
RecruitingPhase 4
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))
Slovenia120 participantsStarted 2025-07-16
Plain-language 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)).
Who can participate
Age range18 Years
SexALL
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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 spon…
What they're measuring
1
Assessment of the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gut microbiota of patients receiving antibiotic