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

The Gut Microbiome Center (Centar za crijevni mikrobiom)

Status: Enrolling

Conditions: Endometriosis; Probiotics

Treatments: Dietary Supplement: Omni Biotic Stress; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06929364

ProMetrioS2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: Under 35 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

patient group 1

Experimental group

Description:

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:

Other: Placebo

Dietary Supplement: Omni Biotic Stress

patient group 2

Experimental group

Description:

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:

Other: Placebo

Dietary Supplement: Omni Biotic Stress