NCT06929364 The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial
| NCT ID | NCT06929364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Gut Microbiome Center (Centar za crijevni mikrobiom) |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-05-01 |
Trial Parameters
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Brief Summary
ProMetrioS is a randomised blinded placebo-controlled cross-over trial investigating the effect of specific multistrain probiotics in patients with endometriosis. The aim of this clinical trial is to determine whether probiotic treatment can significantly modulate gut microbiome composition and functionality in endometriosis patients, specifically parameters associated with the estrobolome.
Eligibility Criteria
Minimum Age: - Maximum Age: 35 Years Sex: Female Gender Based: Ye - only women can participate in this study Accepts Healthy Volunteers: No Inclusion Criteria: * adult subjects with stage III or IV endometriosis diagnosis confirmed by biopsy Exclusion Criteria: * Age \> 35 years * Immunocompromised patients * Patients with chronic inflammatory diseases (e.g., autoimmune disorders) * Pregnancy * Use of supplements and foods with probiotics * Use of immunosuppressant, antibiotic, proton pump inhibitors and corticosteroid drugs * Use of probiotics product less than one month before start of study or during study