Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT04077034
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic Formula DE111® on Immune System in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-30', 'studyFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group', 'timeFrame': '12-week study period (consisting of 8-week treatment plus 4-week follow-up)', 'description': 'Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.'}, {'measure': 'The incidence of adverse events occuring in the experimental group compared to control group', 'timeFrame': '12-week study period (consisting of 8-week treatment plus 4-week follow-up)', 'description': 'Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune System Support']}, 'descriptionModule': {'briefSummary': 'Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent by at least one parent or legal guardian\n* children aged 2 to 6 years\n* attending or about to start attending day-care\n\nExclusion Criteria:\n\n* body weight at birth \\<2500g\n* gestational age \\<37 weeks\n* severe chronic illness\n* regular use of medication\n* immunodeficiency\n* parent or legal guardian not able to understand and comply with requirements of the study'}, 'identificationModule': {'nctId': 'NCT04077034', 'acronym': 'IMMUNOFORM', 'briefTitle': 'Effect of Probiotic Formula DE111® on Immune System in Preschool Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Deerland Enzymes'}, 'officialTitle': 'A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children', 'orgStudyIdInfo': {'id': 'IMMUNO-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Probiotic DE111®', 'interventionNames': ['Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo comparator']}], 'interventions': [{'name': 'Probiotic Formula Bacillus subtilis DE111®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo comparator', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo comparator, once a day for 8 weeks', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3270', 'city': 'Laško', 'country': 'Slovenia', 'facility': 'Health center Laško', 'geoPoint': {'lat': 46.15463, 'lon': 15.23555}}, {'zip': '2000', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'Pediatrija Krebs', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}, {'zip': '2000', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'Pediatrinja d.o.o.', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}, {'zip': '2230', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'Zasebna otroska in solska ambulanta', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}, {'zip': '5290', 'city': 'Šempeter pri Gorici', 'country': 'Slovenia', 'facility': 'Health Center Nova Gorica', 'geoPoint': {'lat': 45.92927, 'lon': 13.64125}}], 'overallOfficials': [{'name': 'Lilijana Kocijancic Besednjak, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Center Nova Gorica'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deerland Enzymes', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vizera d.o.o.', 'class': 'INDUSTRY'}, {'name': 'University of Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}