Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-29 @ 6:34 AM
Study NCT ID:
NCT01934257
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '1996-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-29', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1996-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Infant Temperament Questionnaire', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Infant Characteristic Questionnaire', 'timeFrame': '14 days'}, {'measure': 'Maternal Efficacy Questionnaire', 'timeFrame': '14 days'}, {'measure': 'Mental Health Inventory Questionnaire', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Common Infant Feeding Problems']}, 'referencesModule': {'references': [{'pmid': '25643020', 'type': 'DERIVED', 'citation': "Sherman AL, Anderson J, Rudolph CD, Walker LS. Lactose-Free Milk or Soy-Based Formulas Do Not Improve Caregivers' Distress or Perceptions of Difficult Infant Behavior. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):119-24. doi: 10.1097/MPG.0000000000000743."}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is between 2 and 12 weeks of age\n* Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet\n* Subject has never switched to any lactose free formula\n* The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age\n* The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Subject is in daycare for more than 4 hours per day (20 hours per week)\n* Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding\n* The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment\n* Subject has acute infectious diarrhea or any other intercurrent illness'}, 'identificationModule': {'nctId': 'NCT01934257', 'briefTitle': 'The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems', 'orgStudyIdInfo': {'id': '3332-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Marketed milk-based lactose-containing infant formula', 'interventionNames': ['Other: Marketed milk-based lactose-containing infant formula']}, {'type': 'OTHER', 'label': 'Marketed milk-based lactose-free infant formula', 'interventionNames': ['Other: Marketed milk-based lactose-free infant formula']}, {'type': 'OTHER', 'label': 'Marketed soy-based lactose-free infant formula', 'interventionNames': ['Other: Marketed soy-based lactose-free infant formula']}], 'interventions': [{'name': 'Marketed milk-based lactose-containing infant formula', 'type': 'OTHER', 'armGroupLabels': ['Marketed milk-based lactose-containing infant formula']}, {'name': 'Marketed milk-based lactose-free infant formula', 'type': 'OTHER', 'armGroupLabels': ['Marketed milk-based lactose-free infant formula']}, {'name': 'Marketed soy-based lactose-free infant formula', 'type': 'OTHER', 'armGroupLabels': ['Marketed soy-based lactose-free infant formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80011', 'city': 'Aurora', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Mark Pearlman', 'geoPoint': {'lat': 37.65993, 'lon': -121.00271}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Gould Medical Foundation', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial Medial Center Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Welborn Clinic Peds', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riveria Pediatrics', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatrics', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '70820', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Kids Med South', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Pediatric Group', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Chapel Hill Pediatrics', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28732', 'city': 'Fletcher', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Henderson Pediatrics', 'geoPoint': {'lat': 35.43067, 'lon': -82.50123}}, {'zip': '28105', 'city': 'Matthews', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Matthews Children Group', 'geoPoint': {'lat': 35.11681, 'lon': -80.72368}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Capital Pediatrics', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '19083', 'city': 'Havertown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pediatric Medical Associates', 'geoPoint': {'lat': 39.98095, 'lon': -75.30852}}, {'zip': '18960', 'city': 'Sellersville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennridge Pediatrics', 'geoPoint': {'lat': 40.35399, 'lon': -75.3049}}, {'zip': '15241', 'city': 'Upper Saint Clair', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pittsburgh Pediatric Research', 'geoPoint': {'lat': 40.3359, 'lon': -80.08339}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lewis Gale Clinic', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Vancouver Clinic', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '54501', 'city': 'Rhinelander', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Rhinelander Medical Center', 'geoPoint': {'lat': 45.63662, 'lon': -89.41208}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Dr. David Conner', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Colin Rudolph, M.D., Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson & Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}