Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-06 @ 10:43 PM
Study NCT ID:
NCT07006558
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'After signing the informed consent, participants start taking the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks (phase 1). If the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose (8.4 mg) (phase 2), and repeating the process of doubling doses (16.8 mg) (phase 3), 33.6 mg (phase 4), and 67.2 mg (phase 5).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events (AEs)', 'timeFrame': 'At "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Number of participants with treatment-related adverse events (AEs) experienced during the supplementation, assessed through a questionnaire.'}, {'measure': 'Type of adverse effects (AEs)', 'timeFrame': 'At "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Symptoms of adverse effects (AEs) experienced during the supplementation, assessed through a questionnaire including the different body systems: gastrointestinal, CNS, respiratory, dermatological).'}, {'measure': 'DAO enzymatic activity in serum using a radioextraction immunoassay', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'DAO enzymatic activity in serum (mU/mL) using a radioextraction immunoassay (REA-3H, Laboratorio Echevarne, Barcelona, Spain).'}], 'secondaryOutcomes': [{'measure': 'Dietary habits', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Dietary habits assessed through a dietary weekly record'}, {'measure': 'Histamine in 24h urine', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Histamine in 24h urine'}, {'measure': 'Hemogram', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Hemogram'}, {'measure': 'Glycemia', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Glycemia for safety assessment'}, {'measure': 'HbA1c', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'HbA1c for safety assessment'}, {'measure': 'Ionogram', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Ionogram for safety assessment'}, {'measure': 'Lipid profile', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Lipid profile'}, {'measure': 'C-reactive protein', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'C-reactive protein for safety assessment'}, {'measure': 'Interleukin-6', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Interleukin-6 for safety assessment'}, {'measure': 'Proteinuria', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Proteinuria from urine sample'}, {'measure': 'Urine sediment', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Urine sediment from urine sample for safety assessment'}, {'measure': 'Gastrointestinal symptoms through Rome IV criteria', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported Gastrointestinal symptoms: Rome IV criteria'}, {'measure': 'Gastrointestinal symptoms through Bristol Stool Scale', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported Gastrointestinal symptoms: Bristol Stool Scale. Score goes from Type 1 to Type 7. Higher and lower scores mean worse outcome. Middle scores (Type 3-4) are considered normal/healthy stool consistency.'}, {'measure': 'Gastrointestinal symptoms through Gastrointestinal Quality of Life Index (GIQLI)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported Gastrointestinal symptoms: Gastrointestinal Quality of Life Index (GIQLI). Score goes from 0 to 144. Higher scores indicate a better outcome.'}, {'measure': 'Headaches symptoms through MIDAS questionnaire', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported Headaches symptoms through Migraine Disability Assessment Questionnaire (MIDAS) questionnaire. Score goes from 0 to \\>21 points. Higher scores indicate a worse outcome.'}, {'measure': 'Headaches symptoms through HIT-6 questionnaire', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported Headaches symptoms through Headache Impact Test-6 (HIT-6) questionnaire. Score goes from 36 to 78. Higher scores indicate a worse outcome.'}, {'measure': 'Respiratory symptoms through SNOT-22 questionnaire', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported respiratory symptoms through Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire. Score goes from 0 to 110. Higher scores indicate a worse outcome.'}, {'measure': 'Respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Score goes from 0 to 6. Higher scores indicate a worse outcome.', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)'}, {'measure': 'Dermatological symptoms through SCORAD index', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported dermatological symptoms through SCORing Atopic Dermatitis (SCORAD) index. Score goes from 0 to 103. Higher scores indicate a worse outcome.'}, {'measure': 'Dermatological symptoms through Itch Severity Scale (ISS)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported dermatological symptoms through Itch Severity Scale. Score goes from 0 to 21. Higher scores indicate a worse outcome'}, {'measure': 'Dermatological symptoms through Dermatology Life Quality Index (DLQI)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported dermatological symptoms through Dermatology Life Quality Index (DLQI). Score goes from 0 to 20. Higher scores indicate worse outcomes.'}, {'measure': 'Short-Form Health Survey (SF-36)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Self-reported Short-Form Health Survey (SF-36) Quality of Life. Score goes from 0 to 100. Higher scores indicate a better outcome.'}, {'measure': 'Creatinine (mg/dL)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Creatinine (mg/dL) to assess renal function'}, {'measure': 'Glomerular filtration rate (mL/min/1.73m2)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Glomerular filtration rate (mL/min/1.73m2) to assess renal function'}, {'measure': 'Uric acid (mg/dL)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Uric acid (mg/dL) to assess renal function'}, {'measure': 'Albuminuria (mg/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Albuminuria (mg/L) to assess renal function'}, {'measure': 'Albumin/creatinine ratio', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Albumin (mg/L)/creatinine (mg/dL) ratio; to assess renal function'}, {'measure': 'Urine (mg/g)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Urine (mg/g) ratio; to assess renal function'}, {'measure': 'Urinary pH', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Urinary pH to assess renal function'}, {'measure': 'Urine specific gravity (g/mL)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Urine specific gravity (g/mL) to assess renal function'}, {'measure': 'Aspartate Aminotransferase, ASAT (U/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Aspartate Aminotransferase, ASAT (U/L) to assess hepatic function'}, {'measure': 'Alanine Aminotransferase, ALAT (U/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Alanine Aminotransferase, ALAT (U/L) to assess hepatic function'}, {'measure': 'Gamma-Glutamyl Transferase, GGT (U/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Gamma-Glutamyl Transferase, GGT (U/L) to assess hepatic function'}, {'measure': 'Total Bilirubin (mg/dL)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Total Bilirubin (mg/dL) to assess hepatic function'}, {'measure': 'Alkaline Phosphatase (U/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Alkaline Phosphatase (U/L) to assess hepatic function'}, {'measure': 'Lactate Dehydrogenase (U/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Lactate Dehydrogenase (U/L) to assess hepatic function'}, {'measure': 'Total Proteins (g/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Total Proteins (g/L) to assess hepatic function'}, {'measure': 'Albumin (g/L)', 'timeFrame': 'At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".', 'description': 'Albumin (g/L) to assess hepatic function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diamine oxidase', 'histamine intolerance', 'safety', 'tolerability', 'pea sprout', 'diamine oxidase supplementation'], 'conditions': ['Histamine Intolerance']}, 'descriptionModule': {'briefSummary': 'The present study was conducted to assess the safety and tolerability of five ascending doses of plant-based DAO enzyme supplement in subjects with symptoms of histamine intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent history of 2 or more symptoms associated to histamine intolerance.\n* Altered activity of plasmatic DAO enzyme and/or at least one genetic variants linked to DAO deficiency (rs10156191, rs1049742, rs1049793, rs2052129).\n* Not having started a dietary intervention (low histamine diet or DAO supplementation) before the start of this study.\n\nExclusion Criteria:\n\n* Treatment with low-histamine diet and/or dietary DAO enzyme supplementation prior to the study.\n* Pharmacological treatment with antibiotics or probiotic supplements within the last month prior to enrollment.\n* Breast-feeding or pregnant women.\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07006558', 'acronym': 'HCB/2023/0345', 'briefTitle': 'Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Biotek'}, 'officialTitle': 'Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance', 'orgStudyIdInfo': {'id': 'HCB/2023/0345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 (4.2 mg adiDAO®Veg)', 'description': 'Patients receive the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks.', 'interventionNames': ['Dietary Supplement: Diamino Oxidase']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 (8.4 mg adiDAO®Veg)', 'description': 'If, after phase 1, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 8.4 mg of adiDAO®Veg three times a day.', 'interventionNames': ['Dietary Supplement: Diamino Oxidase']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3 (16.8 mg adiDAO®Veg)', 'description': 'If, after phase 2, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 16.8 mg of adiDAO®Veg three times a day.', 'interventionNames': ['Dietary Supplement: Diamino Oxidase']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 4 (33.6 mg adiDAO®Veg)', 'description': 'If, after phase 3, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 33.6 mg of adiDAO®Veg three times a day.', 'interventionNames': ['Dietary Supplement: Diamino Oxidase']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 5 (67.2 mg adiDAO®Veg)', 'description': 'If, after phase 4, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 67.2 mg of adiDAO®Veg three times a day.', 'interventionNames': ['Dietary Supplement: Diamino Oxidase']}], 'interventions': [{'name': 'Diamino Oxidase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The investigational product is a dehydrated power of DAO enzyme from green pea (Pisum sativum L.) sprouts (adiDAO®Veg, DR Healthcare, S.L.U., Barcelona, Spain), with an enzymatic activity \\> 298 mU/g (\\> 14,500 kHDU/g).', 'armGroupLabels': ['Phase 1 (4.2 mg adiDAO®Veg)', 'Phase 2 (8.4 mg adiDAO®Veg)', 'Phase 3 (16.8 mg adiDAO®Veg)', 'Phase 4 (33.6 mg adiDAO®Veg)', 'Phase 5 (67.2 mg adiDAO®Veg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Serum DAO activity, participant-reported adverse effects (AEs).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Biotek', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}