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

Endometriosis Clinical Trial

— ENDO-DIET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387161
• Other study ID #: 2021-ENDODIET
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University of Pavia
• Contact: Cinzia Ferraris, PhD
• Phone: 3402337242
• Email: cinzia.ferraris[@]unipv.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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).

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
University of Pavia	Fondazione IRCCS Policlinico San Matteo di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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-1ß values (pg/ml)	6 months
Secondary	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