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

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

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 Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Other: Nutritional intervention

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: Cinzia Ferraris, PhD; Phone Number: 3402337242; Email: cinzia.ferraris@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • University of Pavia
    • Contact: Cinzia Ferraris, PhD; Phone Number: +39 0382987868; Email: cinzia.ferraris@unipv.it
    • Principal Investigator: Barbara Gardella, Dott.
    • Sub-Investigator: Monica Guglielmetti, Dott.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational group; 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.

Other: Nutritional intervention; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	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)	6 months

Collaborators and Investigators

• Sponsor: University of Pavia
• Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Study Director: Barbara Gardella, Dott, IRCCS Policlinico San Matteo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: inflammation; diet; endometriosis; chronic pelvic pain
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 2021-ENDODIET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No