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

NCT05387161 | Unknown

• 1 other identifier: 2021-ENDODIET
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

endometriosis; diet; inflammation; chronic pelvic pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function

  6 months

• To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain

  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

  6 months

• 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 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

Study Arms (1)

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

Interventions

Nutritional intervention OTHER

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).

Observational group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

University of Pavia

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis; Inflammation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara Gardella, Dott

  IRCCS Policlinico San Matteo

  STUDY DIRECTOR

Central Study Contacts

Cinzia Ferraris, PhD

CONTACT

3402337242; cinzia.ferraris@unipv.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: May 24, 2022
• Study Start: September 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)