Status:
RECRUITING
Impact of Dietary Guidance and Probiotics in the Treatment of Endometriosis and Irritable Bowel Syndrome in Women
Lead Sponsor:
University of Sao Paulo
Conditions:
Endometriosis
Bowels Irritable
Eligibility:
FEMALE
15-50 years
Phase:
NA
Brief Summary
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, ...
Detailed Description
Endometriosis (EDT) is a chronic, inflammatory, hormone-dependent disease that induces cellular adhesion and proliferation, stimulates vascularization, and disrupts protective immune responses. In its...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2029
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT07149519
Start Date
March 1 2025
End Date
February 15 2029
Last Update
September 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Letícia Ferracini Lenharo Hayashi
Catanduva, São Paulo, Brazil, 15800-050