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Clinical Trials in Italy / NCT07590895
Recruiting Not applicable

Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms

NCT07590895 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase
Not applicable
Started
2024-03-01
Last updated
2026-05-15

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

FODMAP diet

FODMAP diet: Diet low in oligosaccharides, disaccharides, monosaccharides and fermentable polyols

Study summary

The main objective of the study is to assess whether a dietary regimen based on the principles of the FODMAP diet, compared with the current treatment programme which does not include specific dietary recommendations, can improve pain symptoms in patients with symptomatic endometriosis and intestinal symptoms (i.e. bloating, nausea, constipation, diarrhoea and vomiting) attributable to irritable bowel syndrome, compared with a control group

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18 and 45 years * BMI between 18.5 and 24.9, * Surgical, clinical or instrumental diagnosis of endometriosis * Presence of bowel symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) referable to irritable bowel syndrome, on estro-progestin or progestin treatment or in the absence of hormonal treatment Exclusion Criteria: * Associated conditions that may cause pelvic pain independent of the presence of endometriosis (e.g., pelvic varices and salpingitis outcomes) * chronic inflammatory bowel disease (Crohn's disease or ulcerative rectocolitis). * patients with obstructive uropathy, subocclusive intestinal stenosis * complex adnexal masses or typical endometriomas greater than 5 cm in diameter. * women who are obese (BMI ≥ 30) or underweight (BMI \< 18) * women on vegetarian-vegan dietary regimens, * women with metabolic diseases that require specific dietary indications such as in the case of diabetes and celiac disease.

Primary outcome measure(s)

  • Change of pain related syntomps in patients with bowel symptoms — 6 months
    The primary objective of the study is to evaluate whether a dietary regimen based on the principles of the FODMAP diet versus the current treatment program, which does not include specific dietary indications, can change algic symptoms in patients with symptomatic endometriosis and the presence of bowel symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) referable to irritable bowel syndrome, compared with a control group. The outcome will be measured trough Numerical Rating Scale (NRS) on dismenorrea, dyspareunia, non menstrual pelvic pain and dyschezia.

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan Italy Recruiting

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Other trials for the same condition

Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis Recruiting
AAGL 2021 Classification and Surgical Complications in Women With Endometriosis Starting soon
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF Recruiting
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery Starting soon
Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07590895 on ClinicalTrials.gov ↗ ← All trials in Italy