NCT07590895 Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms
| NCT ID | NCT07590895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-03-01 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07590895 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07590895 currently recruiting?
Yes, NCT07590895 is actively recruiting participants. Contact the research team at giussy.barbara@policlinico.mi.it for enrollment information.
Where is the NCT07590895 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07590895 clinical trial?
NCT07590895 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 150 participants.