Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-30 @ 2:46 PM
Study NCT ID:
NCT01137357
Status:
COMPLETED
Last Update Posted:
2010-06-04
First Post:
2010-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics for Reduction Of Markers In Subjects With Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015014', 'term': 'Yogurt'}], 'ancestors': [{'id': 'D043302', 'term': 'Cultured Milk Products'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-03', 'studyFirstSubmitDate': '2010-06-03', 'studyFirstSubmitQcDate': '2010-06-03', 'lastUpdatePostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)'}], 'secondaryOutcomes': [{'measure': 'Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hay Fever', 'Birch Pollen Allergy']}, 'descriptionModule': {'briefSummary': 'In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch pollen allergy is one of the most common forms of respiratory allergy in European countries, and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated for their immunomodulatory properties in birch pollen sensitive subjects outside the hay fever season. A double-blind placebo-controlled parallel study will be performed in which subjects with a proven birch pollen allergy will consume one of 5 different probiotic yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood samples are collected at the start and after 4 weeks. Immune parameters are determined in serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* birch pollen sensitive subjects\n* Positive RAST or intracutane skintest\n* age 18-50\n* signed informed consent form\n\nExclusion Criteria:\n\n* use of probiotics\n* known allergy for pets (home setting)\n* use of medication influencing the immune system\n* use of antibiotics\n* lactose intolerance\n* pregnancy\n* infection'}, 'identificationModule': {'nctId': 'NCT01137357', 'acronym': 'PROMISA', 'briefTitle': 'Probiotics for Reduction Of Markers In Subjects With Allergy', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Probiotics for Reduction Of Markers In Subjects With Allergy', 'orgStudyIdInfo': {'id': 'LTC 559-240908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoghurt with Lactobacillus strain (L.plantarum WCFS1)', 'interventionNames': ['Dietary Supplement: Yoghurt with L. plantarum strain']}, {'type': 'EXPERIMENTAL', 'label': 'Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)', 'interventionNames': ['Dietary Supplement: Yoghurt with L. plantarum strain']}, {'type': 'EXPERIMENTAL', 'label': 'Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)', 'interventionNames': ['Dietary Supplement: Yoghurt with L. plantarum strain']}, {'type': 'EXPERIMENTAL', 'label': 'Yoghurt with Lactobacillus strain (L.plantarum CBS125632)', 'interventionNames': ['Dietary Supplement: Yoghurt with L. plantarum strain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Yoghurt with Lactobacillus casei Shirota', 'interventionNames': ['Dietary Supplement: Yoghurt with L.casei']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Yoghurt', 'interventionNames': ['Dietary Supplement: Yoghurt']}], 'interventions': [{'name': 'Yoghurt with L. plantarum strain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of yoghurt during 4 weeks', 'armGroupLabels': ['Yoghurt with Lactobacillus strain (L.plantarum WCFS1)']}, {'name': 'Yoghurt with L.casei', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of yoghurt during 4 weeks', 'armGroupLabels': ['Yoghurt with Lactobacillus casei Shirota']}, {'name': 'Yoghurt with L. plantarum strain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of yoghurt during 4 weeks', 'armGroupLabels': ['Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)']}, {'name': 'Yoghurt with L. plantarum strain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Yoghurt with L. plantarum strain', 'armGroupLabels': ['Yoghurt with Lactobacillus strain (L.plantarum CBS125632)']}, {'name': 'Yoghurt with L. plantarum strain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of yoghurt during 4 weeks', 'armGroupLabels': ['Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)']}, {'name': 'Yoghurt', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of yoghurt during 4 weeks', 'armGroupLabels': ['Placebo Yoghurt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6824 BJ', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Allergologiepraktijk Arnhem/Radboud/Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'overallOfficials': [{'name': 'A Jansen, Drs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allergologiepraktijk Arnhem/Radboud/Rijnstate'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergologiepraktijk Arnhem/Radboud/Rijnstate', 'class': 'UNKNOWN'}, {'name': 'NIZO Food Research', 'class': 'OTHER'}, {'name': 'Wageningen University', 'class': 'OTHER'}, {'name': 'Campina Innovation', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Drs. A. Jansen', 'oldOrganization': 'Allergologiepraktijk Arnhem/Radboud/Rijnstate'}}}}