Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms
Recruiting now · Not applicable
Conditions studied: Endometriosis
In brief
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
Key facts
- Study ID
- NCT07590895
- Run by
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- People needed
- 150
- Starts
- 2024-03-01
- Expected to finish
- 2026-12-15
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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