Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-01 @ 1:19 PM
Study NCT ID:
NCT01731392
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children Immune Functions(2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-11-16', 'lastUpdatePostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days with diarrhea', 'timeFrame': 'during the 5 months of follow up'}], 'secondaryOutcomes': [{'measure': 'Number of episodes of Upper Respiratory Infections', 'timeFrame': '5 months'}, {'measure': 'Duration of episodes of Upper Respiratory Infections', 'timeFrame': '5 months'}, {'measure': 'Severity of episodes of Upper Respiratory Infections', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diarrhea', 'Children', 'Lactobacilli'], 'conditions': ['Diarrhea', 'Upper Respiratory Infections']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of milk-based formulas on infections and immune functions in healthy children.', 'detailedDescription': 'Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.\n\nThe beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents written and signed informed consent for participation in the study.\n* Healthy children aged 1 to 3 years that are no more breastfed.\n* Go to a selected nursery and / or pediatrician.\n* Parents must have a phone at home or a cellular phone to call the paediatrician.\n* No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.\n* Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.\n* Children not being intensive consumers of regular yoghurts\n\nExclusion Criteria:\n\n* Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).\n* Used antibiotics within the last 30 days prior to V1 (baseline visit).\n* Congenital or chronic disease.\n* Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.\n* Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.'}, 'identificationModule': {'nctId': 'NCT01731392', 'briefTitle': 'Children Immune Functions(2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children', 'orgStudyIdInfo': {'id': '10.50.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Milk with Bifidobacteria', 'description': 'duration of the treatment is 5 months', 'interventionNames': ['Dietary Supplement: Milk with Bifidobacteria']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Milk with non replicating lactobacilli', 'description': 'duration of the treatment is 5 months', 'interventionNames': ['Dietary Supplement: Milk with non replicating lactobacilli']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Semi skimmed milk', 'description': 'duration of the treatment is 5 months', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Milk with Bifidobacteria', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.', 'armGroupLabels': ['Milk with Bifidobacteria']}, {'name': 'Milk with non replicating lactobacilli', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.', 'armGroupLabels': ['Milk with non replicating lactobacilli']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.', 'armGroupLabels': ['Semi skimmed milk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Dept. Nutrition, Faculty of Medicine University of Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Saptawati Bardosono, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nutrition Department, Faculty of Medicine,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}