FODMAP Diet for Pelvic Endometriosis With GI Symptoms
Official title: Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms: a Randomized Controlled Trial
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07590895 · Data updated 2026-11-12
This study tests whether following a low-FODMAP diet can reduce pain and improve quality of life and sexual function in women with endometriosis and gut symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | November 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT07590895 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18-45 with a confirmed endometriosis diagnosis and irritable bowel-like symptoms who are on or off hormonal treatment and have a BMI 18.5–24.9.
✕Probably not a fit
Individuals without gut-related symptoms or whose symptoms are not diet-responsive may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a structured FODMAP dietary regimen to a standard treatment plan without specific dietary guidance in women with surgically or diagnostically confirmed endometriosis and irritable bowel-like symptoms. The aim is to see if reducing certain fermentable carbohydrates lessens pelvic pain and related symptoms. Participants are 18 to 45 years old, with a BMI between 18.5 and 24.9, and are either on hormonal therapy or not. The trial is led by Fondazione IRCCS Ca' Granda and is based in Milan, Italy. Outcomes focus on pain, quality of life, and sexual function, reflecting a holistic view of endometriosis impact.
Why it matters
Potential benefit: If successful, participants may experience reduced pain and improved daily functioning and sexual health related to endometriosis.
How similar studies have gone: Previous data in IBS and related conditions suggest dietary FODMAP modifications can alleviate symptoms, but effects in endometriosis with GI symptoms are less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy Recruiting
Study contacts
- Study coordinator: Giussy Barbara
- Email: giussy.barbara@policlinico.mi.it
- Phone: +393471753089
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.