Erythema Migrans of Lyme DiseasePhase 4SUBLYMENCT06451913
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))
A Phase 4 study testing Amoxicillin + Saccharomyces boulardii CNCM I-745, Stool samples and BSFS : Bristol Stool Form Scale in people with Erythema Migrans of Lyme Disease, run by Biocodex at 1 site in Slovenia.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema Migrans of Lyme Disease
- What is being tested?
- Amoxicillin + Saccharomyces boulardii CNCM I-745, Stool samples and BSFS : Bristol Stool Form Scale
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- 16 Jul 2025to Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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,
Show all 20Show fewer
- 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, HIV,…), patients with a central venous catheter,
- 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 as loperamide, atropine and other cholinergic agents, 4 weeks prior to study enrollment and during the study,
- 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 interventional 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Martina Jaklič, PhD, +386 1 522 2037, martina.jaklic@kclj.si
Katarina Ogrinc, DR
About this study
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)).
Read the detailed description
The study is designed to compare the efficacy of Saccharomyces boulardii CNCM-I-745 500 mg bid to a placebo in patients undergoing antibiotic therapy in the context of erythema migrans as the early form of Lyme borreliosis.
- Conditions
- Erythema Migrans of Lyme Disease
- Being tested
- Amoxicillin + Saccharomyces boulardii CNCM I-745, Amoxicillin + Placebo, Stool samples, BSFS : Bristol Stool Form Scale, GSRS : Gastrointestinal Symptom Rating Scale
- Keywords
- Erythema Migrans, Lyme Disease, Gut microbiota, Saccharomyces boulardii CNCM I-745, Lyme borreliosis
- Medical subject headings
- Erythema Chronicum Migrans, Glossitis, Benign Migratory, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin + Saccharomyces boulardii CNCM I-745Drug
At inclusion visit (V1), the Investigator will dispense and ask the subject to take Amoxicillin 1000 mg bid for 14 days + Saccharomyces boulardii 250 mg x 2 twice a day for 21 days
Amoxicillin + PlaceboDrug
At inclusion visit (V1),the Investigator will dispense and ask the subject to take Amoxicillin 1000 mg bid for 14 days + a matching placebo bid for 21 days
Stool samplesOther
The subject will be asked to collect thanks to four OMNIgene® •GUT OMR-200 kits :
- an initial stool collection when returning home at D1 (in any case before any intake of amoxicillin and of the investigational medication and up to 1 day after D1).
- a stool collection at home after the phone call 1, Day 7 (stool collection up to Day 7 + 1 day)
- a stool collection at home after the phone call 2, Day 14 (stool collection up to Day 14 + 1 day)
- at home the day of the Visit 2, Day 21 (stool collection up to Day 21 + 1 day)
BSFS : Bristol Stool Form ScaleOther
All included subjects will have to complete a stool diary BSFS (Bristol Stool Form Scale) daily and at each bowel movement, from Day 1 until the end of study treatment (Day 21). The patient will fill the form with the date, the time, and the stool texture.
GSRS : Gastrointestinal Symptom Rating ScaleOther
All included subjects will have to complete a GSRS (Gastrointestinal Symptom Response Score) questionnaire weekly from Day 1 until the end of the study treatment (Day 21).
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin + Saccharomyces boulardii CNCM I-745 | Experimental | The patients will received oral Amoxicillin (1000 mg capsules bid) for 14 days and oral Saccharomyces boulardii CNCM I-745 (®) 250 mg x 2 capsules twice a day for 21 days. Receives: Drug: Amoxicillin + Saccharomyces boulardii CNCM I-745; Other: Stool samples; Other: BSFS : Bristol Stool Form Scale; Other: GSRS : Gastrointestinal Symptom Rating Scale |
| Amoxicillin + Placebo | Placebo comparator | The patients will received oral Amoxicillin (1000 mg capsules bid) for 14 days + oral Placebo capsules for 21 days. Receives: Drug: Amoxicillin + Placebo; Other: Stool samples; Other: BSFS : Bristol Stool Form Scale; Other: GSRS : Gastrointestinal Symptom Rating Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gut microbiota of patients receiving antibiotic
Primary endpoint : analysis of the intestinal microbiota in the patient's stools
Measured: At Day 1, Day 7, Day 14 and Day 21
Secondary outcomes (3)
Assessment of the efficacy of Saccharomyces boulardii CNCM I-745 in prevention of antibiotic-associated diarrhoea (AAD) in patients undergoing antibiotic therapy
Secondary efficacy endpoint : 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.
Measured: At Day 1, Day 7, Day 14 and Day 21
Assessment of the efficacy of Saccharomyces boulardii CNCM I-745 on the stools in patients undergoing antibiotic therapy : Recorded stools in the Bristol Stool Form Scale (BSFS)
Secondary efficacy endpoint : Time frame in hours up to the time of the last liquid or loose stool (defined as types 6 or 7 on Bristol Stool Form Scale (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
Measured: At Day 1, Day 7, Day 14 and Day 21
Assess the effect of Saccharomyces boulardii CNCM I-745, an antibiotic, and their combination on the gastro-intestinal symptoms of patients receiving antibiotic therapy : Changes from baseline of the GSRS
Secondary efficacy endpoint : Changes from baseline of the Gastrointestinal Symptom Rating Scale (GSRS) score (total score) and diarrhea sub-scores will be compared weekly between the treatment groups. The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
Measured: Weekly from Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start16 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythema Migrans of Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group, comparative study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oana BERNARD, MD, Study director, Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451913
- Sponsor's protocol ID
- SUBLYME - Sb 241
- Other IDs
- 2023-508694-80-01, 2023
- Acronym
- SUBLYME
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No