Probiotics for treating endometriosis
The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial
NA · The Gut Microbiome Center (Centar za crijevni mikrobiom) · NCT06929364
This study is testing whether taking specific probiotics can help improve gut health and quality of life for people with endometriosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 35 Years |
| Sex | Female |
| Sponsor | The Gut Microbiome Center (Centar za crijevni mikrobiom) (other) |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06929364 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of specific multistrain probiotics on patients with endometriosis. It is a randomized, double-blinded, placebo-controlled, cross-over trial that aims to determine if probiotic treatment can significantly alter gut microbiome composition and functionality in these patients. Participants will undergo a six-month study period, which includes two intervention phases with a washout period in between to allow the gut microbiome to return to baseline. The study will assess various outcome measures, including gut microbiome changes and quality of life, at four distinct time points.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 35 with a confirmed diagnosis of stage III or IV endometriosis.
Not a fit: Patients over 35 years old, immunocompromised individuals, or those with chronic inflammatory diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for managing endometriosis symptoms through gut microbiome modulation.
How similar studies have performed: While the approach of using probiotics in endometriosis is relatively novel, previous studies have shown promising results in gut microbiome modulation for other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zagreb
- University Hospital Center Zagreb — Zagreb, Croatia (RECRUITING)
Study contacts
- Study coordinator: Ira Renko, MS
- Email: ira.renko@gmail.com
- Phone: 955096473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, Probiotics, endometriosis, probiotics, microbiome