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

ConditionsEndometriosisProbiotics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 35
SponsorThe Gut Microbiome Center (Centar za crijevni mikrobiom)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

adult subjects with stage III or IV endometriosis diagnosis confirmed by biopsy

Disqualifiers

Age > 35 years

Immunocompromised patients

Patients with chronic inflammatory diseases (e.g., autoimmune disorders)

Pregnancy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Omni Biotic Stress

    Dietary supplement

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

  • Placebo

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: patient group 1Experimental treatment 2 interventions
Group B: patient group 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in relative abundance of gut microbial taxa and functional pathways related to the estrobolome in fecal samples

The primary outcome is the modulation of the gut microbiome. The fecal microbiome, as a genuine proxy of the gut microbiome, will be analyzed. Specific attention will be brought to taxa and metabolic pathways involved in the estrobolome.

Time frame
At baseline, after 8 weeks (end of phase 1), and after 24 weeks (end of phase 2)

Secondary outcomes

1

Change in quality of life measured by EHP-5 questionnaire

Quality of life will be assessed using the Endometriosis Health Profile-5 (EHP-5) questionnaire at baseline, after each intervention phase, and at the end of the study.

Time frame
Week 1, Week 8, Week 16, Week 24 (6 months)
2

Change in quality of life measured by SEQOL questionnaire

Quality of life will be assessed using the Stellenbosch Endometriosis Quality of Life (SEQOL) questionnaire at baseline, after each intervention phase, and at the end of the study.

Time frame
Week 1, Week 8, Week 16, Week 24 (6 months)

Other outcomes

1

Change in Mediterranean diet adherence (MEDAS score)

Adherence to the Mediterranean diet will be assessed using a validated Mediterranean Diet Adherence Screener (MEDAS) at baseline and after each intervention phase

Time frame
Week 1, Week 8, Week 16, Week 24 (6 months)
2

Change in perceived stress levels (PSS score)

Perceived stress will be measured using the Perceived Stress Scale (PSS) questionnaire at baseline and after each intervention phase.

Time frame
Week 1, Week 8, Week 16, Week 24 (6 months)
3

Change in sleep quantity (self-reported hours of sleep per night)

Participants will self-report average hours of sleep per night using a standardized sleep questionnaire at baseline and after each intervention phase.

Time frame
Week 1, Week 8, Week 16, Week 24 (6 months)
4

Change in physical activity levels (IPAQ score)

Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) at baseline and after each intervention phase.

Time frame
Week 1, Week 8, Week 16, Week 24 (6 months)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Gut Microbiome Center (Centar za crijevni mikrobiom)

Lead sponsor

Clinical Hospital Centre Zagreb

Collaborator

Source ClinicalTrials.gov
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