Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-28 @ 3:50 PM
Study NCT ID:
NCT04672850
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Probiotic and Zinc Supplementation on the Common Cold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms severity', 'timeFrame': 'Three months', 'description': 'Decrease in the severity of symptoms will be determined using a common cold questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Composition of gut and oral microbiome', 'timeFrame': 'Three months', 'description': 'Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing'}, {'measure': 'IgA', 'timeFrame': 'Three months', 'description': 'Changes in levels of IgA in saliva and/or feces will be measured using ELISA'}, {'measure': 'Duration of symptoms', 'timeFrame': 'Three months', 'description': 'Decrease in duration of cold will be determined using a common cold questionnaire'}, {'measure': 'Number of colds', 'timeFrame': 'Three months', 'description': 'Decrease in number of colds will be determined using a common cold questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Common Cold']}, 'descriptionModule': {'briefSummary': 'The purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. The hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. This study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* Diagnosed gastrointestinal disorders\n* Autoimmune diseases or immuno compromized\n* Antibiotic treatment in the last month'}, 'identificationModule': {'nctId': 'NCT04672850', 'briefTitle': 'The Effect of Probiotic and Zinc Supplementation on the Common Cold', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults', 'orgStudyIdInfo': {'id': 'Prozicold'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Rice flour', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': 'Probiotic bacteria, yeast, zinc and rice brand', 'interventionNames': ['Dietary Supplement: Probiotic']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants will consume 2 capsules daily for three months', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants will consume 2 capsules daily for three months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Lunds universitet', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only group data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coradil AB', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Åsa Håkansson', 'investigatorAffiliation': 'Lund University'}}}}