Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT01779895
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Administration and Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)', 'timeFrame': '8 weeks', 'description': 'Compared over 8 weeks between the two treatment groups'}], 'secondaryOutcomes': [{'measure': 'Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells', 'timeFrame': 'Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks'}, {'measure': 'Basophil activation in ex-vivo stimulated whole blood cells', 'timeFrame': 'Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks'}, {'measure': 'Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score', 'timeFrame': 'Measured weekly for the 8 weeks of product intake'}, {'measure': 'Level of Specific Immunoglobulin E', 'timeFrame': 'Measured 2 times: at the start of product intake and after 8 weeks'}, {'measure': 'Frequency of adverse events', 'timeFrame': 'during the 8 weeks of product intake'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dust mite', 'Perennial allergic rhinitis'], 'conditions': ['Rhinitis, Allergic, Perennial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 20-65 years old\n* Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1\n* Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract\n* Body Mass Index 19-29\n* Having obtained his/her informed consent\n\nExclusion Criteria:\n\n* Anemia\n* Allergy to any food or medication\n* Asthma\n* Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments\n* Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening\n* Consumption of probiotic and other dietary nutritional interventions\n* More than 2 drinks/day alcohol consumption or use of illicit drugs\n* Pregnant women\n* Subjects with expected low compliance\n* Blood donation in the past month or planning to donate blood until a month after the end of the study\n* Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study'}, 'identificationModule': {'nctId': 'NCT01779895', 'briefTitle': 'Probiotic Administration and Perennial Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy', 'orgStudyIdInfo': {'id': '12.18.MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NCC2461', 'description': 'probiotic blended in maltodextrin powder to be taken daily', 'interventionNames': ['Dietary Supplement: Lactobacillus paracasei probiotic strain']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus paracasei probiotic strain', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['NCC2461']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Metabolic Unit, Nestlé Research Centre', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Maurice Beaumont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nestlé Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}