The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial
Recruiting · NCT06929364 · Interventional (participants receive a specific treatment) · Lead sponsor: The Gut Microbiome Center (Centar za crijevni mikrobiom)
View the official record on ClinicalTrials.gov →Interventions studied
Omni Biotic StressPlacebo
What this trial is about
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.
Who can take part
Age range
Up to 35 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital Center Zagreb - Zagreb, Croatia