Taking people in CroatiaNo phase

Testing a probiotic supplement in people with endometriosis

Tests whether a probiotic supplement changes gut bacteria in people with endometriosis.

Key facts

Who runs it: The Gut Microbiome Center (Centar za crijevni mikrobiom)
Where: Zagreb, CroatiaSee the site
Trial code: NCT06929364
Registry title: The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial
Status: Recruiting
People taking part: 40 people, planned
Started: 1 Nov 2024
Planned end: 30 Nov 2025
Type of study: Interventional, 2 groups
Treatments tested: Omni Biotic Stress
Placebo
Record updated: 16 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women up to 35 years old with stage III or IV endometriosis confirmed by biopsy. It tests whether probiotics change the gut bacteria.

Age: Adults, up to 35 years old
Sex: Women only
Disease stage: Stage III or IV endometriosis, confirmed by biopsy
Earlier treatment: No probiotic products less than one month before the study or during it. No immunosuppressant, antibiotic, proton pump inhibitor or corticosteroid drugs.

Main reasons for not taking part

Older than 35 years
Weakened immune system
Chronic inflammatory disease, for example an autoimmune disorder
Pregnancy
Use of supplements and foods with probiotics

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

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

Who cannot take part

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
Patients with chronic inflammatory diseases (e.g., autoimmune disorders)
Age > 35 years
Immunocompromised patients
Pregnancy
Use of supplements and foods with probiotics

Other criteria

Minimum Age: - Maximum Age: 35 Years Sex: Female Gender Based: Ye - only women can participate in this study Accepts Healthy Volunteers: No

Where in Croatia

University Hospital Center ZagrebZagreb, CroatiaContact: Ira Renko, MSTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

patient group 1Treatment being tested
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
Treatment: Omni Biotic Stress and Placebo
patient group 2Treatment being tested
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.
Treatment: Omni Biotic Stress and Placebo