The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in relative abundance of gut microbial taxa and functional pathways related to the estrobolome in fecal samples
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
I got error for writing 2 arms and that participants and investigator are masked so I had to adapt it.
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in relative abundance of gut microbial taxa and functional pathways related to the estrobolome in fecal samples
时间窗: At baseline, after 8 weeks (end of phase 1), and after 24 weeks (end of phase 2)
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.
次要结局
- 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))