Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:37 AM
Study NCT ID:
NCT07431658
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (venous blood for oxidative stress biomarkers)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Associations between dietary variables, oxidative stress biomarkers, and clinical outcomes in CSU', 'timeFrame': 'Baseline (and Baseline to 3 months after omalizumab in CSU patients)', 'description': 'Statistical comparisons and correlation/association analyses will evaluate relationships between dietary measures (including antioxidant capacity), oxidative stress biomarkers, and CSU clinical scores (UAS7, UCT, CU-Q2oL).'}], 'primaryOutcomes': [{'measure': 'Disease activity scores (UAS7, UCT) and urticaria quality of life questionnaire (CU-Q2oL)', 'timeFrame': 'Baseline', 'description': 'Disease activity and control will be assessed in CSU patients only using the Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT).\n\nQuality of life will be assessed in CSU patients only using an urticaria quality of life questionnaire (CU-Q2oL)'}, {'measure': 'Oxidative stress biomarkers (TOK, TAK, AOPP, MDA; OSI calculated)', 'timeFrame': 'Baseline', 'description': 'From routine venous blood samples, Total Oxidant Capacity (TOK), Total Antioxidant Capacity (TAK), Advanced Oxidation Protein Products (AOPP), and Malondialdehyde (MDA) will be measured; Oxidative Stress Index (OSI) will be calculated as the TOK/TAK ratio.'}, {'measure': 'Dietary intake / dietary antioxidant capacity based on 3-day dietary record', 'timeFrame': 'Baseline', 'description': 'Dietary intake will be captured using three non-consecutive 24-hour dietary records (two weekdays, one weekend day). Dietary antioxidant capacity will be calculated using Oxygen Radical Absorbance Capacity (ORAC) with BeBiS 9.0 (Nutrition Information System).'}], 'secondaryOutcomes': [{'measure': 'Change in urticaria disease activity score (UAS7: Urticaria Activity Score over 7 days), urticaria control (UCT: Urticaria Control Test) and urticaria-related quality of life questionnaire score (CU-Q2oL)', 'timeFrame': 'Baseline to 3 months (after initiation of omalizumab)', 'description': 'All participants in the chronic spontaneous urticaria (CSU) patient group will initiate omalizumab (standard-of-care) and change in UAS7, UCT, CU-Q2oL will be reassessed after 3 months following omalizumab treatment'}, {'measure': 'Change in oxidative stress biomarkers in venous blood (TOK, TAK, AOPP, MDA, OSI)', 'timeFrame': 'Baseline to 3 months after initiation of omalizumab', 'description': 'Change in Total Oxidant Capacity (TOK), Total Antioxidant Capacity (TAK), Advanced Oxidation Protein Products (AOPP), Malondialdehyde (MDA) and calculated Oxidative Stress Index (OSI) in chronic spontaneous urticaria (CSU) patient group from baseline to Month 3 after initiate omalizumab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic spontaneous urticaria', 'oxidative stress', 'dietary antioxidant capacity', 'omalizumab', 'UAS7', 'UCT', 'AOPP', 'MDA', 'total oxidant status', 'total antioxidant status', 'OSI', 'ORAC'], 'conditions': ['Chronic Spontaneous Urticaria (CSU)']}, 'descriptionModule': {'briefSummary': 'Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.', 'detailedDescription': 'This is an observational, case-control study including 58 adults (18-65 years) with active chronic spontaneous urticaria recruited from a dermatology outpatient clinic and 58 age- and BMI-matched healthy volunteers. Demographic/clinical data and comorbidities will be recorded. Dietary intake will be captured using three non-consecutive 24-hour food consumption records (two weekdays, one weekend day). Food portions will be estimated using a standardized food photo catalogue and analyzed with BeBiS 9.0 to compute macro/micronutrients, glycemic index/load, and dietary antioxidant capacity using ORAC. Venous blood will be used to measure total oxidant status (TOS/TOK), total antioxidant status (TAS/TAK), advanced oxidation protein products (AOPP), and malondialdehyde (MDA), and to calculate oxidative stress index (OSI). In CSU patients, disease activity will be evaluated using UAS7 and the Urticaria Control Test (UCT), as well as an urticaria quality of life questionnaire. CSU patients with a clinical indication for omalizumab will be re-evaluated after 3 months, repeating dietary records, biomarker measurements, and clinical scores to assess treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with active CSU and age/BMI-matched healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* CSU group: diagnosis of chronic spontaneous urticaria, active CSU, and written informed consent\n* Control group: healthy volunteers with similar characteristics (age/BMI-matched)\n\nExclusion Criteria:\n\n* Additional dermatologic, metabolic, endocrinologic, systemic inflammatory disease; malignancy (diagnosis or suspicion)\n* Use within last 3 months of anti-inflammatory drugs or drugs that may affect serum glucose/lipids\n* Special diet/nutrition status; antioxidant supplement use\n* Smoking or alcohol use\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07431658', 'briefTitle': 'Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'Investigation of the Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab Treatment in Patients With Chronic Spontaneous Urticaria', 'orgStudyIdInfo': {'id': 'SBU-IEAH-KAEK-20251205-294'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: Chronic Spontaneous Urticaria (CSU) Patients', 'description': '58 adults with active CSU'}, {'label': 'Cohort 2: Healthy Controls', 'description': '58 healthy volunteers matched by age and BMI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Training and Research Hospital, Dermatology and Venereology Clinic Cerrahpaşa Mh. Org. Abdurrahman Nafiz Gürman Cd. No:24, 34098 Fatih, Istanbul, Turkey', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatology Resident', 'investigatorFullName': 'Emine Ecem Hakkoymaz', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}