The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial
NCT ID: NCT06929364
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-11-01
2025-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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
Omni Biotic Stress
Multistrain probiotic formulation (Omni Biotic Stress), 1 sachet daily for 8 weeks
Placebo
Inert powder identical in appearance and taste to probiotic, 1 sachet daily for 8 weeks
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.
Omni Biotic Stress
Multistrain probiotic formulation (Omni Biotic Stress), 1 sachet daily for 8 weeks
Placebo
Inert powder identical in appearance and taste to probiotic, 1 sachet daily for 8 weeks
Interventions
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Omni Biotic Stress
Multistrain probiotic formulation (Omni Biotic Stress), 1 sachet daily for 8 weeks
Placebo
Inert powder identical in appearance and taste to probiotic, 1 sachet daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
35 Years
FEMALE
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
The Gut Microbiome Center (Centar za crijevni mikrobiom)
OTHER
Responsible Party
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Locations
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University Hospital Center Zagreb
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ProMetrioS2024
Identifier Type: -
Identifier Source: org_study_id
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