Clinical trial NCT05387161: Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis
Official title: Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis and chrOnic Pelvic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: endometriosis
diet
inflammation
chronic pelvic pain
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2022-05-24
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the Endometriosis Outpatient Clinic of the Gynecological Clinic of the San Matteo Polyclinic in Pavia will be enrolled and will agree to participate in the study and have signed the relative informed consent.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome 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.
timeFrame: 6 months
measure: The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (quality of life) in women suffering from endometriosis with chronic pelvic pain.
timeFrame: 6 months
measure: The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (intestinal function) in women suffering from endometriosis with chronic pelvic pain.
timeFrame: 6 months
Secondary outcomes:
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function
timeFrame: 6 months
measure: To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain
timeFrame: 6 months
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression
timeFrame: 6 months
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component
timeFrame: 6 months
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some routine blood chemistry parameters
timeFrame: 6 months
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker
timeFrame: 6 months
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers
timeFrame: 6 months
measure: The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
affiliation: IRCCS Policlinico San Matteo
name: Barbara Gardella, Dott
role: STUDY_DIRECTOR
References: