Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01067027
Status:
UNKNOWN
Last Update Posted:
2011-06-29
First Post:
2010-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-28', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-10', 'lastUpdatePostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.', 'timeFrame': '7, 14 and 21 days'}], 'secondaryOutcomes': [{'measure': 'Number of responders versus non-responders with L. reuteri versus placebo at end of the study.', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colic', 'Colic in Breast-fed Infants'], 'conditions': ['Colic']}, 'descriptionModule': {'briefSummary': 'It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '14 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ifants aged between 14 and 60 days\n* Breast fed, exclusively during length of trial\n* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.\n* Debut of colic symptoms 6+/-1 days before randomization\n* Gestational age between 37 and 42 weeks\n* Apgar score higher than 7 at 5 minutes\n* Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period\n* Written informed consent from one or both parents\n* Stated availability throughout the study period\n\nExclusion Criteria:\n\n* Major chronic disease\n* Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria\n* Administration of anitbiotics the week before randomization\n* Administration of probiotics the week before randomization\n* Participation in other clinical trials"}, 'identificationModule': {'nctId': 'NCT01067027', 'briefTitle': 'Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri', 'organization': {'class': 'OTHER', 'fullName': "Children's Investigational Research Program, LLC"}, 'officialTitle': 'Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri', 'orgStudyIdInfo': {'id': 'Colic001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 drops of study product 30 minutes before feeding.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Misty R Ross, MA', 'role': 'CONTACT', 'email': 'mross@chirpresearch.com', 'phone': '479-254-6772', 'phoneExt': '21'}, {'name': 'Tonya D Hogue, Coordinator', 'role': 'CONTACT', 'email': 'thogue@chirpresearch.com', 'phone': '479-254-6772', 'phoneExt': '22'}], 'facility': "Children's Investigational Research Program", 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}], 'centralContacts': [{'name': 'Misty R Ross, MA', 'role': 'CONTACT', 'email': 'mross@chirpresearch.com', 'phone': '479-254-6772', 'phoneExt': '21'}], 'overallOfficials': [{'name': 'Bryan M Harvey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Investigational Research Program"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Investigational Research Program, LLC", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bryan M. Harvey, M.D.', 'oldOrganization': "Children's Investigational Research Program"}}}}