Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00823056
Status:
COMPLETED
Last Update Posted:
2012-04-24
First Post:
2009-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Probiotics on Infections in Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 454}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-22', 'studyFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fewer infections', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'growth', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Infections', 'Children'], 'conditions': ['Diarrhoea', 'Respiratory Diseases']}, 'referencesModule': {'references': [{'pmid': '23602437', 'type': 'DERIVED', 'citation': 'Nielsen AC, Gyhrs ML, Nielsen LP, Pedersen C, Bottiger B. Gastroenteritis and the novel picornaviruses aichi virus, cosavirus, saffold virus, and salivirus in young children. J Clin Virol. 2013 Jul;57(3):239-42. doi: 10.1016/j.jcv.2013.03.015. Epub 2013 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.\n\nThe investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.', 'detailedDescription': 'Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.\n\nOur hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010\n* Gestational age \\> 36. weeks\n\nExclusion Criteria:\n\n* Chronical heart or lung conditions\n* Short Bowel Syndrome\n* CVC (Central Venous Catheter)'}, 'identificationModule': {'nctId': 'NCT00823056', 'briefTitle': 'The Effect of Probiotics on Infections in Toddlers', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'The Effect of Probiotics on Infections in Toddlers', 'orgStudyIdInfo': {'id': 'Version 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Dietary Supplement: probiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: probiotics']}], 'interventions': [{'name': 'probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo', 'armGroupLabels': ['1']}, {'name': 'probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': '0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4300', 'city': 'Holbæk', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Paediatr. Depart., University Hospital Holbaek, University of Copenhagen', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}], 'overallOfficials': [{'name': 'Mette L. Gyhrs, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ph.d student'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Holbaek Sygehus', 'class': 'OTHER'}, {'name': 'Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK', 'class': 'UNKNOWN'}, {'name': 'Chr Hansen', 'class': 'INDUSTRY'}, {'name': 'Ferrosan A/S', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Ms. Mette Louise Gyhrs, MD.', 'oldOrganization': 'Paediatr. Depart., Uni. Hosp. Holbaek, Region Zealand,DK, Uni. of CPH'}}}}