Impact of Dietary Guidance and Probiotics in the Treatment of Endometriosis and Irritable Bowel Syndrome in Women
Recruiting · NCT07149519 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Sao Paulo
View the official record on ClinicalTrials.gov →Interventions studied
probiotics - Lactobacillus spp
What this trial is about
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.
Who can take part
Age range
15 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Letícia Ferracini Lenharo Hayashi - Catanduva, São Paulo, Brazil