Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-01 @ 9:45 AM
Study NCT ID:
NCT02013934
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2013-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics in Prevention of Common Cold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 899}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2016-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of cold symptoms', 'timeFrame': '3 months', 'description': 'Severity of cold symptoms based on the questionnaire WURSS-21 during the cold episodes throughout the study period, in comparison between verum and placebo group'}], 'secondaryOutcomes': [{'measure': 'Incidence of common cold episodes', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Viral Infections of the Upper Respiratory Tract']}, 'referencesModule': {'references': [{'pmid': '33296464', 'type': 'DERIVED', 'citation': 'Ahren IL, Hillman M, Nordstrom EA, Larsson N, Niskanen TM. Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial. J Nutr. 2021 Jan 4;151(1):214-222. doi: 10.1093/jn/nxaa353.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* males and females\n* age 18-70 years\n* increased risk for common cold (at least 4 episodes within 12 months)\n* commitment to adhere to former diet and physical activity\n* commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)\n* women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.\n\nExclusion Criteria:\n\n* acute / chronic upper / lower airways disease\n* chronic cough of any origin\n* any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)\n* history of nasal reconstructive surgery\n* presence of nasal ulcers or nasal polyps\n* severe nasal septum deviation or other condition that could cause nasal obstruction\n* congenital or acquired immunodeficiency disease (e.g. HIV infection)\n* Bechterew's disease\n* body temperature above 37.5°C\n* suspected swine flu or influenza\n* vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study\n* vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study\n* stomach/gastrointestinal diseases\n* serious organ or systemic diseases\n* sleep disorder\n* psychiatric disorders\n* known sensitivity to the ingredients of the investigational product\n* regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start\n* habitual usage of nasal drops/spray\n* pregnancy or nursing\n* alcohol / drug abuse\n* simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days\n* insufficient compliance"}, 'identificationModule': {'nctId': 'NCT02013934', 'briefTitle': 'Probiotics in Prevention of Common Cold', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probi AB'}, 'officialTitle': 'Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold', 'orgStudyIdInfo': {'id': 'PAB/011013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'description': 'Dietary supplement', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dietary supplement', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'A&R', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probi AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}