BridgeMD
New treatment option for Erythema Migrans of Lyme Disease
Official title 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))
ClinicalTrials.gov ID: NCT06451913
What this study is testing
What is Amoxicillin + Saccharomyces boulardii CNCM I-745?
Amoxicillin + Saccharomyces boulardii CNCM I-745 is an investigational medicine, given as a twice-daily, being studied as a potential treatment for erythema migrans of lyme disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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,
See the full eligibility 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...
- 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.