Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT01507935
Status:
WITHDRAWN
Last Update Posted:
2012-09-05
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colonisation Resistance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was withdrawn due to change of the study product formulation.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-08', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiota composition and its metabolic activity', 'timeFrame': 'Week 6', 'description': '* Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut\n* Metabolic activity of the gut microbiota: pH, SCFA, lactate'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal symptoms (incidence and severity)', 'timeFrame': 'Week 1, Week 3, Week 6, Week 8'}, {'measure': 'Anthropometry', 'timeFrame': 'Week 1, Week 3, Week 6, Week 8'}, {'measure': 'Number, type and severity of (serious) adverse events', 'timeFrame': 'Week 1, Week 3, Week 6, Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy infants', 'Infant formula', 'Prebiotics oligosaccharides', 'Colonisation Resistance', 'Gut Microbiota'], 'conditions': ['Healthy Infants']}, 'descriptionModule': {'briefSummary': 'This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '8 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion\n* Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)\n* Parents' or guardian's written informed consent\n\nExclusion Criteria:\n\n* Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)\n* Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards\n* Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)\n* Significant congenital abnormality that could affect the study results\n* Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study\n* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study\n* Gastroenteritis in the last two weeks before inclusion"}, 'identificationModule': {'nctId': 'NCT01507935', 'acronym': 'ColoR', 'briefTitle': 'Colonisation Resistance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Asia Pacific Holdings Pte, Ltd.'}, 'officialTitle': 'Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants', 'orgStudyIdInfo': {'id': 'COL.1.C/A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group I', 'description': "Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I", 'interventionNames': ["Other: Regular non-hydrolysed cow's milk"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group II', 'description': "Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II", 'interventionNames': ["Other: Regular non-hydrolysed cow's milk"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': "Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides", 'interventionNames': ["Other: Regular non-hydrolysed cow's milk"]}, {'type': 'NO_INTERVENTION', 'label': 'Reference group', 'description': 'Exclusively breast-fed infants'}], 'interventions': [{'name': "Regular non-hydrolysed cow's milk", 'type': 'OTHER', 'description': "Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I", 'armGroupLabels': ['Intervention Group I']}, {'name': "Regular non-hydrolysed cow's milk", 'type': 'OTHER', 'description': "Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II", 'armGroupLabels': ['Intervention Group II']}, {'name': "Regular non-hydrolysed cow's milk", 'type': 'OTHER', 'description': "Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides", 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Phramongkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sungkom Jongpiputvanich, A/Prof., MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Asia Pacific Holdings Pte, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}