NCT07149519Recruiting
Impact of Dietary Guidance and Probiotics in the Treatment of Endometriosis and Irritable Bowel Syndrome in Women
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- University of Sao Paulo
- Diseases
- Endometriosis
- NCT number
- NCT07149519
What you commit to
- Study type: Interventional
- Planned participants: 74
- From 1 Mar 2025 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Endometriosis requiring surgical treatment during the study period;
- Inability to use oral medication;
Other illness
- 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;
- 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);
- History of alcohol or drug dependence;
- Inability to cooperate with investigators due to cognitive impairment or mental state.
Other
- 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;
- Pregnancy or lactation;
- Smoking in the last three years;
Who the study is looking for
- 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
Age in the registry: 15 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Letícia Ferracini Lenharo Hayashi Coordinator of this site? Confirm its status | Catanduva | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.