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

April 14, 2025 updated by: The Gut Microbiome Center (Centar za crijevni mikrobiom)
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited among the outpatient population of the National Center for Endometriosis, Department of Gynecological Surgery and Urology, Gynecology Department, University Hospital Center Zagreb following the inclusion and exclusion criteria.

To participate in the study all patients will be required to sign the Informed Consent form.

All patients will undergo a complete anamnesis via a digital form to investigate their lifestyle (occupation, stress, diet, physical activity level).

The study period will be 6 months: eight weeks on either option (verum/placebo), with an eight week washout period in between. The purpose of the washout period is to allow the gut microbiome to return to baseline. The washout period was determined based on previous gut microbiota studies with a similar design (reference), based on the fact that the gut microbiota can change rapidly (< 7 days) r.

The outcome measures (gut microbiome, quality of life) will be assessed in four distinct time points in context of the planned intervention.

T1 - before the intervention (start-of-study)

T2 - after the first intervention cycle/phase 1 (verum/placebo) of two months

T3 - after the wash-out phase of two months

T4 - after the second intervention cycle/phase 2 (verum/placebo) of two months (end-of-study)

Stool sampling will be performed with the aid of specific kits indepently by the patients. Lifestyle and quality of life will be evaluated by an online form designed specifically for the purpose of this study in Microsoft Office Forms (Microsoft, San Francisco, USA), short Online Form.

Through the process of randomization, patients will be allocated to either first receive the verum (probiotic) or the placebo (maltodextrin), and second the placebo or verum inversely.

Both patients and researchers involved will be blinded (double-blind study), the patients will be informed that they are going to take a probiotic twice for two months with a two-month time division. The intervention will consist of treatment with a multistrain probiotic formulation (Omni Biotic Stress) and the placebo which is identical in all its characteristics and packaging. Patients will be instructed to consume one sachet a day of each (probiotic) for 8 weeks and to report any symptoms or side effects related to its use. Adherence control will be carried out through the patient's notes on a separate online form provided, and also by checking the number of sachets used.

Since this is a cross-over study, data will be compared between time-points T1 and T2, and time-points T3 and T4, with the goal of minimizing the potential effect if we find that the effect of the probiotics lasted longer than eight weeks in those randomized into the intervention arm first.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University hospital center Zagreb
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ira Renko, MS
        • Sub-Investigator:
          • Andrija Karacic, dr.med
        • Sub-Investigator:
          • Mislav Mikus, dr.med.
        • Sub-Investigator:
          • Ana-Maria Liberati Prso, dr.med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient group 1

Arm 1: Probiotic-Placebo Sequence Description: Participants will consume Omni Biotic Stress (multistrain probiotic formulation) once daily for 8 weeks during the first phase, followed by an 8-week washout period, and then placebo once daily for 8 weeks during the second phase.

Interventions:

Dietary Supplement: Omni Biotic Stress; Other: Placebo
Dietary supplement: Omni Biotic Stress
Multistrain probiotic formulation (Omni Biotic Stress), 1 sachet daily for 8 weeks
Other: Placebo
Inert powder identical in appearance and taste to probiotic, 1 sachet daily for 8 weeks
Experimental: patient group 2

Arm 2: Placebo-Probiotic Sequence Description: Participants will consume placebo once daily for 8 weeks during the first phase, followed by an 8-week washout period, and then Omni Biotic Stress once daily for 8 weeks during the second phase.

Interventions:

Other: Placebo; Dietary Supplement: Omni Biotic Stress

Participants will record adherence and any potential side effects in an online form. Researchers will check the number of used sachets to ensure accuracy of adherence data.
Dietary supplement: Omni Biotic Stress
Multistrain probiotic formulation (Omni Biotic Stress), 1 sachet daily for 8 weeks
Other: Placebo
Inert powder identical in appearance and taste to probiotic, 1 sachet daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in relative abundance of gut microbial taxa and functional pathways related to the estrobolome in fecal samples
Time Frame: At baseline, after 8 weeks (end of phase 1), and after 24 weeks (end of phase 2)
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.
At baseline, after 8 weeks (end of phase 1), and after 24 weeks (end of phase 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life measured by EHP-5 questionnaire
Time Frame: Week 1, Week 8, Week 16, Week 24 (6 months)
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.
Week 1, Week 8, Week 16, Week 24 (6 months)
Change in quality of life measured by SEQOL questionnaire
Time Frame: Week 1, Week 8, Week 16, Week 24 (6 months)
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.
Week 1, Week 8, Week 16, Week 24 (6 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mediterranean diet adherence (MEDAS score)
Time Frame: Week 1, Week 8, Week 16, Week 24 (6 months)
Adherence to the Mediterranean diet will be assessed using a validated Mediterranean Diet Adherence Screener (MEDAS) at baseline and after each intervention phase
Week 1, Week 8, Week 16, Week 24 (6 months)
Change in perceived stress levels (PSS score)
Time Frame: Week 1, Week 8, Week 16, Week 24 (6 months)
Perceived stress will be measured using the Perceived Stress Scale (PSS) questionnaire at baseline and after each intervention phase.
Week 1, Week 8, Week 16, Week 24 (6 months)
Change in sleep quantity (self-reported hours of sleep per night)
Time Frame: Week 1, Week 8, Week 16, Week 24 (6 months)
Participants will self-report average hours of sleep per night using a standardized sleep questionnaire at baseline and after each intervention phase.
Week 1, Week 8, Week 16, Week 24 (6 months)
Change in physical activity levels (IPAQ score)
Time Frame: Week 1, Week 8, Week 16, Week 24 (6 months)
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) at baseline and after each intervention phase.
Week 1, Week 8, Week 16, Week 24 (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Gut Microbiome Center (Centar za crijevni mikrobiom)

Collaborators

Clinical Hospital Centre Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProMetrioS2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

That has to be decided more with the whole team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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