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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a probiotic treatment on the gut health of patients who are receiving antibiotic therapy for a condition known as erythema migrans, which is an early skin form of Lyme disease. The treatment being tested is called Saccharomyces boulardii CNCM I-745, a type of beneficial yeast that is often used to support gut health. The study will also involve the use of an antibiotic called amoxicillin, which is commonly prescribed to treat bacterial infections, including those associated with Lyme disease. Additionally, some participants will receive a placebo, which looks like the treatment but contains no active ingredients.

The purpose of the study is to understand how Saccharomyces boulardii CNCM I-745, either alone or in combination with amoxicillin, affects the gut microbiota, which is the community of microorganisms living in the intestines. Participants in the study will take the treatments orally in the form of capsules. The study will last for a period of up to 21 days, during which time participants will be monitored for changes in their gut health and any side effects they may experience.

Throughout the study, participants will be asked to keep a diary of their bowel movements and any symptoms they experience. This information will help researchers assess the impact of the treatments on gut health and the occurrence of antibiotic-associated diarrhea. The study aims to provide valuable insights into how probiotics like Saccharomyces boulardii CNCM I-745 can support gut health during antibiotic treatment for conditions such as erythema migrans.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be adults, 18 years or older, prescribed antibiotic therapy for erythema migrans, a skin form of Lyme disease.
Participants must be able to comply with study requirements, provide informed consent, and maintain a regular bowel movement schedule.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health metrics. This includes a review of medical history and a physical examination.
For women of childbearing potential, a negative pregnancy test is required before starting the study treatment.
Step 3
Medication administration
Participants receive amoxicillin 1000 mg, taken orally twice a day for 14 days.
In addition, participants may receive Saccharomyces boulardii CNCM I-745, a probiotic, in the form of 250 mg capsules, or a placebo capsule with no active ingredient.
Step 4
Daily monitoring
Participants are required to maintain a daily stool diary, recording stool consistency using the Bristol Stool Form Scale (BSFS).
This diary helps track any episodes of antibiotic-associated diarrhea (AAD) and changes in stool patterns.
Step 5
Weekly assessments
Weekly assessments are conducted to monitor changes in gut microbiota and overall health.
These assessments include evaluating bacterial and fungal diversity, as well as any adverse events or changes in vital signs.
Step 6
Final assessment
At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment on gut microbiota and any changes in health status.
The study aims to conclude by January 29, 2025.

Who can join the trial?

8 criteria

Must be an adult, **18 years or older**.
Must have been prescribed **antibiotic therapy** for **erythema migrans**, which is an early skin form of Lyme disease.
Must be able to follow the study requirements and sign a consent form before any study procedures begin.
Must not have any condition that could interfere with the study assessments.
Must be able to fill out a diary about bowel movements, as per the doctor's opinion.
Must have regular bowel movements, with at least about three times a week.
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For women who can become pregnant:
- Must have a **negative urine pregnancy test** right before starting the study treatment.
- Must agree to use approved methods of **contraception** during the entire study, unless they are post-menopausal, which means having no menstrual periods for 12 months without any other cause.

Who cannot join the trial?

2 criteria

Patients who are currently receiving antibiotic therapy. Antibiotic therapy means taking medicine to fight bacterial infections.
Patients with erythema migrans, which is an early skin form of Lyme disease. Lyme disease is an illness caused by bacteria from tick bites.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
University Medical Center Ljubljana
Ljubljana, Slovenia
Responsive
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Vilnius, Lithuania

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Investigated drugs

Saccharomyces boulardii CNCM I-745
is a type of probiotic yeast. In this trial, it is being studied to see how it affects the gut microbiota, which is the community of microorganisms living in the intestines. The goal is to understand if this probiotic can help maintain a healthy balance of gut bacteria in patients who are taking antibiotics for erythema migrans, an early skin form of Lyme disease.
Antibiotic
is a type of medication used to treat bacterial infections. In this trial, it is used to treat patients with erythema migrans, which is an early skin form of Lyme disease. The study aims to observe how the antibiotic affects the gut microbiota and whether the combination with Saccharomyces boulardii CNCM I-745 can help support gut health during treatment.

What is already known about the treatment

Saccharomyces boulardii CNCM I-745 – This medication is administered orally in the form of capsules or powder. It is currently being studied in clinical trials to evaluate its effects on gut microbiota in patients undergoing antibiotic therapy, particularly those with erythema migrans, an early skin form of Lyme disease. Saccharomyces boulardii is a probiotic yeast that helps maintain and restore the natural balance of the gut flora. It is classified as a probiotic supplement and is not an antibiotic itself, but it is used alongside antibiotics to support digestive health.

Investigated diseases

Lyme Borreliosis – Lyme borreliosis, also known as Lyme disease, is an infectious disease caused by the bacterium Borrelia burgdorferi, transmitted to humans through the bite of infected black-legged ticks. The early skin form of this disease is characterized by erythema migrans, a circular rash that often appears at the site of the tick bite. This rash may expand over time and can be accompanied by flu-like symptoms such as fever, headache, and fatigue. If untreated, the infection can spread to joints, the heart, and the nervous system. The progression of symptoms can vary, with some individuals experiencing more severe manifestations than others. Early detection and management are crucial to prevent further complications.