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

NCT06929364 | Recruiting

• 1 other identifier: ProMetrioS2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Probiotics

Keywords

endometriosis; probiotics; microbiome

Outcome Measures

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.

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

Secondary Outcomes (2)

• Change in quality of life measured by EHP-5 questionnaire

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

• Change in quality of life measured by SEQOL questionnaire

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

Other Outcomes (4)

• Change in Mediterranean diet adherence (MEDAS score)

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

• Change in perceived stress levels (PSS score)

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

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

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

Study Arms (2)

patient group 1

EXPERIMENTAL

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; Other: Placebo

patient group 2

EXPERIMENTAL

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; Other: Placebo

Interventions

Omni Biotic Stress DIETARY_SUPPLEMENT

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

patient group 1; patient group 2

Placebo OTHER

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

patient group 1; patient group 2

Eligibility Criteria

• Age: Up to 35 Years
• Gender Eligibility Details: just women can participate in this study
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Gut Microbiome Center (Centar za crijevni mikrobiom): lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

University Hospital Center Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Ira Renko, MS

CONTACT

955096473; ira.renko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: I got error for writing 2 arms and that participants and investigator are masked so I had to adapt it.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: April 16, 2025
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CR (1)