Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis
NCT ID: NCT05387161
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
65 participants
OBSERVATIONAL
2020-09-01
2023-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
FEMALE
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
University of Pavia
OTHER
Responsible Party
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Cinzia Ferraris
Researcher
Principal Investigators
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Barbara Gardella, Dott
Role: STUDY_DIRECTOR
IRCCS Policlinico San Matteo
Locations
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University of Pavia
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-ENDODIET
Identifier Type: -
Identifier Source: org_study_id
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