Letícia Ferracini Lenharo Hayashi
Catanduva, São Paulo, 15800-050, Brazil
Location status: Recruiting
NCT Number: NCT07149519
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.
Interested in participating?
Request Info15 year–50 year
Female
Interventional
Not applicable
Catanduva, São Paulo, 15800-050, Brazil
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group 1: Specific dietary guidance (low-FODMAP diet ) combined with placebo Group 2: Specific dietary guidance (low-FODMAP diet ) combined with probiotic Group 3: Control - Exclusive habitual diet After the 12-week period, we will evaluate the clinical improvement response of pelvic pain
Other names: Low FODMAPs dietary
Time frame: 12 weeks
visual analogic scale (EVA) EVA ranging from 0,0-10,0 Higher scores indicate worse pain.
Time frame: 12 week
Gastrointestinal Quality of Live Index - GIQLI. Global score GIQLI ranging from 0-144. For the unweighted display of the global score and the dimensions, sum all item scores across the 5 domains to calculate the overall GIQLI score.
Improvement in quality of life will be assessed by the change in the Global Score. Higher scores indicate better quality of life.
Time frame: 12 weeks
Bristol scale. Categorizes stool consistency into seven types. Types 1 and 2 indicate constipation; types 3 and 4 are ideal stools, easy to defecate and without excess liquid; type 5 indicates a lack of fiber in the diet; and types 6 and 7 indicate diarrhea.
Time frame: 12 weeks
Food record and FODMAPS analysis by Monash University
Time frame: 12 weeks
DNA extraction and genetic sequencing using the microway technique. Microbiota diversity will be assessed by alpha diversity (number of OTUs, Chao index) and beta diversity (weighted and unweighted UniFrac). Operational taxonomic units (OTUs) with a global abundance of less than 0.01% or presence in less than 25% of samples will be excluded from the analysis.
University of Sao Paulo
Other
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
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