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.
Study Type
OBSERVATIONAL
Enrollment
65
The nutritional intervention will consist in providing general nutritional indications specific for endometriosis and an indicative ungrammatical daily diet plan, which must be followed for the entire period of intervention (6 months).
University of Pavia
Pavia, Italy
RECRUITINGThe 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.
The outcome will be assessed with repeated measurements using the following parameters: -Evaluation of chronic pelvic pain, dysmenorrhea, dyschezia and dysuria: VAS visual analogue scale, from 0 to 10 points where 10 points indicates worst pain
Time frame: 6 months
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.
The outcome will be assessed with repeated measurements using the following parameters: Quality of life: measurement of physical and mental components with SF36 consisting of two components, one physical and one mental. Both fall within a range from 0 to 100 points where higher values are associated with better health
Time frame: 6 months
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.
The outcome will be assessed with repeated measurements using the following parameters: Bowel Function: Knowles-Eccersley-Scott Symptom Questionnaire (KESS) (points)
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire: Sexual Function: FSFI questionnaire (points)
Time frame: 6 months
To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire: Urinary function and bladder pain: PUF and O's Leary / Sant questionnaire (points)
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire: Beck Depression Inventory (BDI) (points)
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component
The outcomes necessary to respond to the secondary objective are the administration of the following questionnaires: Alexithymia Scale (TAS) questionnaire (points)
Time frame: 6 months
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
The outcomes necessary to respond to the secondary objective are the administration of the following routine blood chemistry parameters: Measure Ca125 (unità/ml) and Vitamin D (ng/ml)
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker
The outcomes necessary to respond to the secondary objective are the administration of the following test: fecal calprotectin (mg/kg)
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers
The outcomes necessary to respond to the secondary objective are the administration of the following Inflammatory markers: IL-6 and IL-1β values (pg/ml)
Time frame: 6 months
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins
The outcomes necessary to respond to the secondary objective are the administration of the following measurement of proteins: C-reactive protein values (mg/dL)
Time frame: 6 months
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