Erythema migrans Trials in Disease

Study on the Effects of Saccharomyces boulardii CNCM I-745 and Amoxicillin on Gut Health in Patients with Early Lyme Disease Undergoing Antibiotic Treatment

This clinical trial focuses on understanding how probiotic treatment can support gut health in patients receiving antibiotic therapy for the early skin form of Lyme disease. The study is being conducted in four countries: Czechia, Slovakia, Lithuania, and Slovenia.

Main inclusion criteria: Participants must be adults aged 18 years or older who have been prescribed antibiotic treatment for this condition. They need to have regular bowel movements of at least three times per week and be able to keep a diary tracking their bowel habits. Women of childbearing potential must have a negative pregnancy test before starting the study treatment and agree to use approved contraception methods throughout the study period.

Main exclusion criteria: Patients who are already receiving antibiotic therapy at the time of enrollment cannot participate in this study.

Focus and goal of the trial: The study aims to investigate how Saccharomyces boulardii CNCM I-745, a beneficial probiotic yeast, affects the gut microbiota when used alongside antibiotic treatment. Researchers want to understand whether this probiotic can help maintain a healthy balance of intestinal bacteria during the 14-day antibiotic course. Participants will take amoxicillin 1000 mg twice daily along with either the probiotic capsules or placebo capsules. Throughout the treatment period, patients will maintain a daily diary recording their stool consistency and any symptoms. The study includes weekly assessments to monitor changes in gut bacterial and fungal diversity, as well as tracking any episodes of antibiotic-associated diarrhea. The trial is designed to last up to 21 days and aims to provide valuable insights into supporting digestive health during antibiotic treatment.

Investigational drugs: The main investigational product is Saccharomyces boulardii CNCM I-745, administered in 250 mg capsules. This probiotic yeast is being studied for its potential to support gut health and maintain the natural balance of intestinal microorganisms. The study also uses amoxicillin, a commonly prescribed antibiotic for treating bacterial infections associated with Lyme disease, to understand how the combination of probiotic and antibiotic affects the gut environment.