Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 6:15 AM
Study NCT ID:
NCT05387161
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2022-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '6 months', 'description': 'The outcome will be assessed with repeated measurements using the following parameters:\n\n-Evaluation of chronic pelvic pain, dysmenorrhea, dyschezia and dysuria: VAS visual analogue scale, from 0 to 10 points where 10 points indicates worst pain'}, {'measure': '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.', 'timeFrame': '6 months', 'description': 'The outcome will be assessed with repeated measurements using the following parameters:\n\nQuality 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'}, {'measure': '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.', 'timeFrame': '6 months', 'description': 'The outcome will be assessed with repeated measurements using the following parameters:\n\nBowel Function: Knowles-Eccersley-Scott Symptom Questionnaire (KESS) (points)'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function', 'timeFrame': '6 months', 'description': 'The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire:\n\nSexual Function: FSFI questionnaire (points)'}, {'measure': 'To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain', 'timeFrame': '6 months', 'description': "The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire:\n\nUrinary function and bladder pain: PUF and O's Leary / Sant questionnaire (points)"}, {'measure': 'The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression', 'timeFrame': '6 months', 'description': 'The outcomes necessary to respond to the secondary objective are the administration of the following questionnaire:\n\nBeck Depression Inventory (BDI) (points)'}, {'measure': 'The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component', 'timeFrame': '6 months', 'description': 'The outcomes necessary to respond to the secondary objective are the administration of the following questionnaires:\n\nAlexithymia Scale (TAS) questionnaire (points)'}, {'measure': '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', 'timeFrame': '6 months', 'description': 'The outcomes necessary to respond to the secondary objective are the administration of the following routine blood chemistry parameters:\n\nMeasure Ca125 (unità/ml) and Vitamin D (ng/ml)'}, {'measure': 'The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker', 'timeFrame': '6 months', 'description': 'The outcomes necessary to respond to the secondary objective are the administration of the following test:\n\nfecal calprotectin (mg/kg)'}, {'measure': 'The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers', 'timeFrame': '6 months', 'description': '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)'}, {'measure': 'The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins', 'timeFrame': '6 months', 'description': 'The outcomes necessary to respond to the secondary objective are the administration of the following measurement of proteins: C-reactive protein values (mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'diet', 'inflammation', 'chronic pelvic pain'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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) .\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of endometriosis +/- chronic pelvic pain\n* No menopause (at least 1 menstrual cycle in the previous 6 months)\n* Informed consent from the patient and / or an authorized legal representative\n\nExclusion Criteria:\n\n* Postmenopause\n* Pregnancy\n* Hysterectomy or oophorectomy\n* Chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, Chron's disease, ulcerative colitis, cystic fibrosis)\n* History of kidney stones, cancer (except basal cell carcinoma) or diabetes\n* Modification in the course of the therapeutic intervention of the therapy for endometriosis"}, 'identificationModule': {'nctId': 'NCT05387161', 'acronym': 'ENDO-DIET', 'briefTitle': 'Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis and chrOnic Pelvic Pain', 'orgStudyIdInfo': {'id': '2021-ENDODIET'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational group', 'description': "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.\n\nIn 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.\n\nThe 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.\n\nAt the end of the 6 months, all anthropometric assessments, blood chemistry and stool tests will be repeated, together with the questionnaires.", 'interventionNames': ['Other: Nutritional intervention']}], 'interventions': [{'name': 'Nutritional intervention', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Observational group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cinzia Ferraris, PhD', 'role': 'CONTACT', 'email': 'cinzia.ferraris@unipv.it', 'phone': '+39 0382987868'}, {'name': 'Barbara Gardella, Dott.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Monica Guglielmetti, Dott.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Cinzia Ferraris, PhD', 'role': 'CONTACT', 'email': 'cinzia.ferraris@unipv.it', 'phone': '3402337242'}], 'overallOfficials': [{'name': 'Barbara Gardella, Dott', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Policlinico San Matteo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Cinzia Ferraris', 'investigatorAffiliation': 'University of Pavia'}}}}