Dietary guidance and probiotics for pelvic pain in women with endometriosis and IBS
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
This trial will try dietary guidance and Lactobacillus probiotics to see if they reduce chronic pelvic pain in women who have both endometriosis and irritable bowel syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Catanduva, São Paulo) |
| Trial ID | NCT07149519 on ClinicalTrials.gov |
What this trial studies
Participants with endometriosis and coexisting irritable bowel syndrome will be randomized to different intervention arms that include dietary guidance and use of Lactobacillus probiotics. The study will follow participants over a treatment period to record changes in chronic pelvic pain and bowel symptoms. Investigators will compare symptom scores between the groups to determine whether non‑pharmacological approaches relieve pain and improve bowel habits. The trial aims to clarify the role of diet and gut microbiota modulation in managing these overlapping conditions.
Who should consider this trial
Good fit: Women aged 18–50 with diagnosed endometriosis and concurrent irritable bowel syndrome who can give informed consent and agree to be randomized and participate exclusively during the study period are ideal candidates.
Not a fit: Women with severe or uncontrolled chronic medical conditions, or with other gastrointestinal diseases such as inflammatory bowel disease or celiac disease, and those outside the 18–50 age range are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the interventions could reduce chronic pelvic pain and improve bowel symptoms and quality of life using non‑drug approaches.
How similar studies have performed: Previous studies of anti‑inflammatory diets and some probiotic trials have reported symptom improvements in endometriosis and IBS, but evidence is mixed and larger randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women between 18 and 50 years of age who wish to participate in the clinical trial; 2. Willingness to voluntarily participate in the study and accept randomization to any of the three treatment arms; 3. Participating exclusively in this clinical trial during the study period; 4. Signing the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP) and CONEP Exclusion Criteria: 1. 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; 2. 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; 3. Endometriosis requiring surgical treatment during the study period; 4. Severe eating disorders, such as: bulimia, anorexia nervosa, and binge-eating disorder; 5. 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); 6. Patients who already consume healthy foods or are on a restrictive diet more than four days a week, which may affect the evaluation results; 7. Patients whose stool protopastological examination is altered; 8. Inability to use oral medication; 9. Pregnancy or lactation; 10. History of alcohol or drug dependence; 11. Smoking in the last three years; 12. Inability to cooperate with investigators due to cognitive impairment or mental state.
Where this trial is running
Catanduva, São Paulo
- Letícia Ferracini Lenharo Hayashi — Catanduva, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.