Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis (ENDO-DIET)

University of Pavia

Status: Enrolling

Conditions: Endometriosis

Treatments: Other: Nutritional intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05387161

2021-ENDODIET

Details and patient eligibility

About

The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention.

The primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.

The first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) .

The second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.

Enrollment: 65 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of endometriosis +/- chronic pelvic pain
• No menopause (at least 1 menstrual cycle in the previous 6 months)
• Informed consent from the patient and / or an authorized legal representative

Exclusion criteria

• Postmenopause
• Pregnancy
• Hysterectomy or oophorectomy
• Chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, Chron's disease, ulcerative colitis, cystic fibrosis)
• History of kidney stones, cancer (except basal cell carcinoma) or diabetes
• Modification in the course of the therapeutic intervention of the therapy for endometriosis

Trial design

65 participants in 1 patient group

Observational group

Description:

A nutritional assessment will be held with the detection of anthropometric parameters. Each participant will be asked to fill in the SF36, the VAS scales, the KESS questionnaire, the SFFI questionnaire, the Questionnaire PUF and O'Leary/Santn, the BDI and the TAS for an assessment of the psychological component. In addition, patients will be asked to fill in a FFQ of food consumption and a 7 days food diary. Finally, routine blood chemistry tests will also be performed, to which will be added those for measuring the inflammatory state and stool examination for the evaluation of fecal Calprotectin for the measurement of intestinal inflammatory markers. The nutritional intervention will consist in providing general nutritional indications specific for endometriosis and an indicative daily diet plan, which must be followed for 6 months. At the end of the 6 months, all anthropometric assessments, blood chemistry and stool tests will be repeated, together with the questionnaires.

Treatment:

Other: Nutritional intervention