RecruitingNot ApplicableNCT06929364

The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial


Sponsor

The Gut Microbiome Center (Centar za crijevni mikrobiom)

Enrollment

40 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMax Age: 35 Years

Inclusion Criteria2

  • Minimum Age: - Maximum Age: 35 Years Sex: Female Gender Based: Ye - only women can participate in this study Accepts Healthy Volunteers: No
  • adult subjects with stage III or IV endometriosis diagnosis confirmed by biopsy

Exclusion Criteria7

  • 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

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Interventions

DIETARY_SUPPLEMENTOmni Biotic Stress

Multistrain probiotic formulation (Omni Biotic Stress), 1 sachet daily for 8 weeks

OTHERPlacebo

Inert powder identical in appearance and taste to probiotic, 1 sachet daily for 8 weeks


Locations(1)

University Hospital Center Zagreb

Zagreb, Croatia

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NCT06929364


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