Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02586558
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Recruitment issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2015-10-23', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant crying and fussing behaviour', 'timeFrame': '6 weeks', 'description': 'As assessed by the Barr Baby Behavior Diary'}], 'secondaryOutcomes': [{'measure': 'Infant crying and fussing behaviour', 'timeFrame': '6 weeks', 'description': 'As assessed by actigraphy and accelerometry'}, {'measure': 'Stool Microbiota', 'timeFrame': '6 weeks'}, {'measure': 'Stool calprotectin', 'timeFrame': '6 weeks'}, {'measure': 'Parent satisfaction', 'timeFrame': '6 weeks', 'description': 'As assessed by parent survey'}, {'measure': 'Infant behaviour', 'timeFrame': '6 weeks', 'description': 'As assessed by parent survey'}, {'measure': 'Infant feeding patterns', 'timeFrame': '6 weeks', 'description': 'As assessed by parent survey'}, {'measure': 'Infant stool patterns', 'timeFrame': '6 weeks', 'description': 'As assessed by parent survey'}, {'measure': 'Postnatal depression', 'timeFrame': '6 weeks', 'description': 'As assessed by parent survey'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colic']}, 'descriptionModule': {'briefSummary': 'Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, term infant from a singleton birth (=\\>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour\n\nExclusion Criteria:\n\n* Infants with known genetic syndromes; birth weight (\\<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy'}, 'identificationModule': {'nctId': 'NCT02586558', 'acronym': 'CRI', 'briefTitle': 'Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study', 'orgStudyIdInfo': {'id': 'INCH-681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Infant Formula', 'description': 'Milk-based infant formula with prebiotics', 'interventionNames': ['Other: Experimental Infant formula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference group', 'description': 'Milk-based infant formula without prebiotics', 'interventionNames': ['Other: Reference group']}], 'interventions': [{'name': 'Experimental Infant formula', 'type': 'OTHER', 'description': 'Ready-to-feed infant formula to be fed ad libitum', 'armGroupLabels': ['Experimental Infant Formula']}, {'name': 'Reference group', 'type': 'OTHER', 'description': 'Ready-to-feed infant formula to be fed ad libitum', 'armGroupLabels': ['Reference group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8P 1H6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'David Braley Health Sciences Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'John Cairney, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Cairney', 'investigatorAffiliation': 'McMaster University'}}}}