Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT01808105
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2013-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth and Tolerance of Infants Fed Infant Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-30', 'studyFirstSubmitDate': '2013-03-07', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Study Formula Intake', 'timeFrame': 'Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits', 'description': 'Average volume of study formula intake and average number of study formula feedings per day'}, {'measure': 'Oligosaccharides', 'timeFrame': 'Study Day (SD) 42 and 119 visits', 'description': 'Infant urine sample'}], 'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Study Day (SD) 14 - 119', 'description': 'Weight gain per day'}], 'secondaryOutcomes': [{'measure': 'Stool Characteristics', 'timeFrame': 'Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits', 'description': 'Stool consistency and number per day'}, {'measure': 'Feeding Tolerance', 'timeFrame': 'Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits', 'description': '% of feedings with spit up associated with feeding'}, {'measure': 'Length', 'timeFrame': 'Study Day (SD) 1, 14, 28, 42, 84 and 119 visits', 'description': 'Length and interval length gain per day'}, {'measure': 'Head Circumference', 'timeFrame': 'Study Day (SD) 1, 14, 28, 42, 84 and 119 visits', 'description': 'Head circumference (HC) and interval HC gain per day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth and Tolerance']}, 'referencesModule': {'references': [{'pmid': '37242222', 'type': 'DERIVED', 'citation': "Hill DR, Buck RH. Infants Fed Breastmilk or 2'-FL Supplemented Formula Have Similar Systemic Levels of Microbiota-Derived Secondary Bile Acids. Nutrients. 2023 May 17;15(10):2339. doi: 10.3390/nu15102339."}, {'pmid': '27798337', 'type': 'DERIVED', 'citation': "Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26."}]}, 'descriptionModule': {'briefSummary': 'To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton from full term birth with a gestational age 37-42 weeks\n* Birth weight \\> 2490 g (\\~5 lbs 8 oz)\n* Between 0 and 5 days of age\n* Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period\n* Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,\n* Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study\n* No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional\n\nExclusion Criteria:\n\n* Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development\n* Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled\n* Treatment with antibiotics\n* Mother intends to use a combination of breast and formula feeding'}, 'identificationModule': {'nctId': 'NCT01808105', 'briefTitle': 'Growth and Tolerance of Infants Fed Infant Formulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Growth and Tolerance of Young Infants Fed Infant Formulas', 'orgStudyIdInfo': {'id': 'AL06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Human Milk', 'description': 'Reference group, breast feeding ad libitum', 'interventionNames': ['Other: Human Milk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Formula', 'description': 'Ready to feed infant formula, feed ad libitum', 'interventionNames': ['Other: Control Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Formula 1', 'description': 'Ready to feed infant formula with human milk oligosaccharides, feed ad libitum', 'interventionNames': ['Other: Experimental Formula 1']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Formula 2', 'description': 'Ready to feed infant formula with human milk oligosaccharides, feed ad libitum', 'interventionNames': ['Other: Experimental Formula 2']}], 'interventions': [{'name': 'Control Formula', 'type': 'OTHER', 'otherNames': ['Commercially available Infant Formula'], 'description': 'Feeding ad libitum', 'armGroupLabels': ['Control Formula']}, {'name': 'Experimental Formula 1', 'type': 'OTHER', 'description': 'Feeding ad libitum', 'armGroupLabels': ['Experimental Formula 1']}, {'name': 'Experimental Formula 2', 'type': 'OTHER', 'description': 'Feeding ad libitum', 'armGroupLabels': ['Experimental Formula 2']}, {'name': 'Human Milk', 'type': 'OTHER', 'otherNames': ['Breast feeding group'], 'description': 'Feeding ad libitum', 'armGroupLabels': ['Human Milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'W.O.M.B Watching Over Mothers and Babies', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '80920', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Research Advantage/Colorado Springs Health Partners', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatric Group, PC', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantic Clinical Research Collaborative', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Lake Mary Pediatrics', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'SCORE Physician Alliance, LLC', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF, College of Medicine, Dept of Pediatrics', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Regional Research Group (SERRG)', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '47720', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'PediaResearch, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northpoint Pediatrics, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Lafayette Clinical Research', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': "Women's Clinic of Lincoln, PC", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45406', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Clinical Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association, Inc', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Institute of Clinical Research', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Clinical Trials of America', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Red Lion Pediatrics', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '65104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford Research', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Tanner Memorial Clinic', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Rockwood Clinic, PS', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '00784', 'city': 'Guayama', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico', 'geoPoint': {'lat': 17.98413, 'lon': -66.11378}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Ponce School of Medicine/ CAIMED Center', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}], 'overallOfficials': [{'name': 'Jennifer Williams, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}