Impact of Dietary Guidance and Probiotics in the Treatment of Chronic Pelvic Pain Secondary to Endometriosis and Irritable Bowel Syndrome in Women: A Randomized, Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- pain improvement
研究概览
简要总结
Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities.
详细描述
Endometriosis (EDT) is a chronic, inflammatory, hormone-dependent disease that induces cellular adhesion and proliferation, stimulates vascularization, and disrupts protective immune responses. In its intestinal form, endometriosis can lead to abdominal pain, dyschezia, and both cyclic and non-cyclic changes in bowel habits. Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS, which is a disorder characterized by brain-gut interactions and inflammation, presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Anti-inflammatory diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. Given the already documented alteration of the gut microbiota and the female reproductive tract, and their dysbiosis associated with the development of EDT and IBS, the investigators are encouraged to further explore the connection between them. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities. By doing so, the investigators aim to underscore the significance of exploring non-pharmacological treatments and to provide new insights for advancing the understanding and management of endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 50 years of age who wish to participate in the clinical trial;
- •Willingness to voluntarily participate in the study and accept randomization to any of the three treatment arms;
- •Participating exclusively in this clinical trial during the study period;
- •Signing the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP) and CONEP
排除标准
- •Chronic, severe, or uncompensated clinical conditions, such as: malnutrition (BMI <18); insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension; lung disease such as asthma or other chronic obstructive pulmonary disease; hematologic and liver diseases; advanced-stage chronic kidney disease (grades 3, 4, and 5); metabolic disorders; and immunosuppression;
- •Clinical conditions of the gastrointestinal tract that cause IBS-like symptoms, such as: inflammatory bowel disease (Chron's disease, ulcerative colitis), microscopic colitis, celiac disease, and lactose intolerance;
- •Endometriosis requiring surgical treatment during the study period;
- •Severe eating disorders, such as: bulimia, anorexia nervosa, and binge-eating disorder;
- •Chronic use of any medication with potential interaction with probiotics, the intestinal microbiota, or the natural progression of the disease in the last 6 months (such as probiotics, antibiotics, antifungals, antihistamines, digestive medications, or treatments for constipation or diarrhea);
- •Patients who already consume healthy foods or are on a restrictive diet more than four days a week, which may affect the evaluation results;
- •Patients whose stool protopastological examination is altered;
- •Inability to use oral medication;
- •Pregnancy or lactation;
- •History of alcohol or drug dependence;
- •Smoking in the last three years;
- •Inability to cooperate with investigators due to cognitive impairment or mental state.
研究组 & 干预措施
Arm 1: Specific dietary guidance associated with placebo.
Patients in this group will receive, within 24 hours of randomization, guidance on a low-FODMAP diet, which must be followed for 12 weeks (120 days), and placebo.
干预措施: probiotics - Lactobacillus spp (Dietary Supplement)
Arm 2: Specific dietary guidance combined with probiotics.
Patients in this group will receive, within 24 hours of randomization, the same low-FODMAP diet guidance combined with probiotics (Lactobacillus and L. gasseri combinations) administered orally once daily for 12 weeks.
干预措施: probiotics - Lactobacillus spp (Dietary Supplement)
Arm 3: Control - exclusive habitual diet
Patients in this group will be instructed to maintain their usual diet and will be administered a placebo. After the 12-week period, if the active treatment group (Arm 1 and 2) has shown a satisfactory clinical response, we will offer specific dietary guidance and probiotics to the control group participants who did not show clinical improvement.
结局指标
主要结局
pain improvement
时间窗: 12 weeks
visual analogic scale (EVA) EVA ranging from 0,0-10,0 Higher scores indicate worse pain.
次要结局
- improvement in quality of life associated with bowel function(12 week)
- improvement of bowel function(12 weeks)
- nutritional analysis(12 weeks)
- analysis of intestinal microbiota(12 weeks)
研究者
Letícia Lenharo
Principal investigator
University of Sao Paulo