Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT03731494
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Systemic Nickel Allergy Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-02', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-03', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoL: Short-Form 36-Item Health Survey (SF-36v2)', 'timeFrame': 'Change from baseline index at 12 months', 'description': 'Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively.'}, {'measure': 'QoL: Psychological General Well Being Index (PGWBI)', 'timeFrame': 'Change from baseline index at 12 months', 'description': 'The PGWBI consists of 22 questions, which deal with six factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment.The response format is graded 1-6 (i.e. total range 22-132), with the highest value corresponding to optimal well-being.'}], 'secondaryOutcomes': [{'measure': 'Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2)', 'timeFrame': 'Baseline.', 'description': 'The MMPI-2 questionnaire containing 567 items with 2 choices of answer ("true" or "false") in order to assess the main structural features of personality and emotional disorders.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nickel allergy', 'Systemic nickel allergy syndrome', 'Health-related quality of life', 'Nickel oral hyposensitizing treatment', 'Diet', 'Short-Form 36-Item Health Survey', 'Psychological General Well Being Index', 'Minnesota Multiphasic Personality Inventory'], 'conditions': ['Systemic Nickel Allergy Syndrome', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS).', 'detailedDescription': 'Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.\n\nIt is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.\n\nAlthough a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Researchers enrol patients suffer from Systemic Nickel Allergy Syndrome (SNAS), condition characterised by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Nickel-rich foods, especially vegetables.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),\n* positive Ni-patch test,\n* clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,\n* positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),\n* written informed consent.\n\nExclusion Criteria:\n\n* age \\< 18 years and \\> 65 years,\n* other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth,\n* diabetes mellitus,\n* hepatic, renal or cardiac dysfunction,\n* thyroid disease or tumor,\n* concomitant treatment with steroids and/or antihistamines in the previous 4 weeks, pregnancy, lactation,\n* smoking, abuse of alcohol, coffee, tea, and cola intake,\n* refusal to participate.'}, 'identificationModule': {'nctId': 'NCT03731494', 'briefTitle': 'Quality of Life in Systemic Nickel Allergy Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Quality of Life Assessment Before and After Hyposensitization Treatment in Systemic Nickel Allergy Syndrome', 'orgStudyIdInfo': {'id': '1377/15 (13939/14)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nickel oral hyposensitization treatment', 'description': 'The patients take capsules at different doses in nickel content until reaching the maximum dose of 1.5 mcg per week for a total of 12 months.', 'interventionNames': ['Biological: Nickel oral hyposensitization treatment']}], 'interventions': [{'name': 'Nickel oral hyposensitization treatment', 'type': 'BIOLOGICAL', 'otherNames': ['NiOHT - TIO Nickel'], 'description': 'Nickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected.', 'armGroupLabels': ['Nickel oral hyposensitization treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Catholic University of Sacred Heart', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Eleonora Nucera, MD,Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of Sacred Heart'}, {'name': 'Antonio Gasbarrini, MD,Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catholic University of Sacred Heart'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Eleonora Nucera', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}