Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms
Recruiting · NCT07590895 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
View the official record on ClinicalTrials.gov →Interventions studied
FODMAP diet
What this trial is about
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
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico - Milan, Italy