Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 11:08 AM
Study NCT ID:
NCT01717534
Status:
COMPLETED
Last Update Posted:
2013-08-27
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children Immune Functions
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'}]}}, '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': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-26', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days with diarrhea', 'timeFrame': 'during 5 months of study period'}], 'secondaryOutcomes': [{'measure': 'Number of episodes of upper respiratory infections', 'timeFrame': 'during 5 months'}, {'measure': 'Duration of upper respiratory infections', 'timeFrame': 'during 5 months'}, {'measure': 'Severity of upper respiratory infections', 'timeFrame': 'during 5 months'}, {'measure': 'Severity of gastrointestinal infections', 'timeFrame': 'during 5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diarrhea', 'Children', 'Heat-treated lactobacilli'], 'conditions': ['Diarrhea', 'Upper Respiratory Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.', 'detailedDescription': 'The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parents written and signed informed consent for participation in the study: parents agree with the participation in the study, dated and signed informed consent form prior to any study related procedure.\n2. Healthy children aged 1 to 4 years\n3. No more breastfed.\n4. Daily home cared and going to a selected pediatrician.\n5. Parents must have a phone at home or a cellular phone to call the paediatrician.\n6. No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period.\n7. Children not being intensive consumers of regular yoghurts\n8. Parents are able to keep a daily record of symptoms and to administrate the study products.\n\nExclusion Criteria:\n\n1. Vaccine administration within the last 3 months prior study start.\n2. Used antibiotics within the last month\n3. Congenital or chronic disease.\n4. Any kind of immunodeficiency or allergy.\n5. Acute infection or fever.\n6. Significant illness within the two weeks prior to the start of the study.'}, 'identificationModule': {'nctId': 'NCT01717534', 'briefTitle': 'Children Immune Functions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children', 'orgStudyIdInfo': {'id': '10.42.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heat-treated lactobacilli', 'description': 'One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.\n\nThe duration of the treatment is 5 months.', 'interventionNames': ['Dietary Supplement: heat-treated lactobacilli or placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin', 'description': 'One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.\n\nThe duration of the treatment is 5 months.', 'interventionNames': ['Dietary Supplement: heat-treated lactobacilli or placebo']}], 'interventions': [{'name': 'heat-treated lactobacilli or placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplement of sachet with 1 g of powder over a 5 months period.', 'armGroupLabels': ['Heat-treated lactobacilli', 'Maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54055', 'city': 'Tlalnepantla', 'state': 'Edo. de Méx', 'country': 'Mexico', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 19.54005, 'lon': -99.19538}}, {'zip': '76000', 'city': 'Querétaro City', 'state': 'Querétaro', 'country': 'Mexico', 'facility': 'Centro de Estudios Clinicos de Queretaro S.c.', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}], 'overallOfficials': [{'name': 'Angeles Nava Hernández, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Clinical Research of Querétaro'}, {'name': 'Carlos A. Mena Cedillos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}