Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis

Recruiting

• Conditions: Endometriosis
• Interventions: Other: Nutritional intervention

• Registration Number: NCT05387161
• Lead Sponsor: University of Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	Nutritional intervention	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.

Primary Outcome Measures

Name	Time	Method
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.	6 months	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
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.	6 months	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
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.	6 months	The outcome will be assessed with repeated measurements using the following parameters: Bowel Function: Knowles-Eccersley-Scott Symptom Questionnaire (KESS) (points)

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function	6 months	The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire: Sexual Function: FSFI questionnaire (points)
To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain	6 months	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)
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression	6 months	The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire: Beck Depression Inventory (BDI) (points)
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	6 months	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)
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins	6 months	The outcomes necessary to respond to the secondary objective are the administration of the following measurement of proteins: C-reactive protein values (mg/dL)
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component	6 months	The outcomes necessary to respond to the secondary objective are the administration of the following questionnaires: Alexithymia Scale (TAS) questionnaire (points)
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers	6 months	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)
The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker	6 months	The outcomes necessary to respond to the secondary objective are the administration of the following test: fecal calprotectin (mg/kg)

Trial Locations

Locations (1)

University of Pavia; 🇮🇹 Pavia, Italy