Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-14 @ 5:20 AM
Study NCT ID:
NCT02118935
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2014-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056692', 'term': 'Prebiotics'}], 'ancestors': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'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': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Measures (Amount of time awake and asleep in a 72 hour period)', 'timeFrame': '14 weeks'}, {'measure': 'Infant State (Infant behavior over a 72 hour period)', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'Achieved Weight', 'timeFrame': '14 weeks', 'description': 'Total weight gain'}, {'measure': 'Achieved Length', 'timeFrame': '14 weeks', 'description': 'Total length gain'}, {'measure': 'Achieved Head Circumference', 'timeFrame': '14 weeks', 'description': 'Total head circumference gain'}, {'measure': 'Formula Intake', 'timeFrame': '14 weeks'}, {'measure': 'Fecal microbiome', 'timeFrame': 'Baseline and 112 days of age'}, {'measure': 'Medically-confirmed Adverse Events', 'timeFrame': '14 weeks'}, {'measure': 'Salivary Cortisol levels', 'timeFrame': '70 and 120 days of age'}, {'measure': 'Temperament - Infant Behavior Questionnaire', 'timeFrame': 'Once at 112 days of age'}, {'measure': 'Sleep Characteristics', 'timeFrame': '14 weeks', 'description': 'Amount of waking and sleeping, number of waking and sleep episodes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Behavioral Measures of Tolerance']}, 'descriptionModule': {'briefSummary': 'The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Days', 'minimumAge': '14 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton, 14-35 days of age at baseline\n* Term infant with birth weight of a minimum of 2500 grams\n* Solely formula-fed\n* Signed Informed Consent and Protected Health Information authorization\n\nExclusion Criteria:\n\n* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised\n* Feeding difficulties or formula intolerance\n* Maternal history of illicit drug use or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT02118935', 'briefTitle': 'Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance', 'orgStudyIdInfo': {'id': '6023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Previously marketed cow's milk-based infant formula", 'interventionNames': ["Other: Previously marketed cow's mlik-based infant formula"]}, {'type': 'EXPERIMENTAL', 'label': "Marketed cow's milk-based infant formula with prebiotics", 'interventionNames': ["Other: Marketed cow's milk-based infant formula with prebiotics"]}], 'interventions': [{'name': "Previously marketed cow's mlik-based infant formula", 'type': 'OTHER', 'armGroupLabels': ["Previously marketed cow's milk-based infant formula"]}, {'name': "Marketed cow's milk-based infant formula with prebiotics", 'type': 'OTHER', 'armGroupLabels': ["Marketed cow's milk-based infant formula with prebiotics"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Pediatric Clinic', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatrics', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '47725', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Universty of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Woburn Pediatrics', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pediatric Associates of Mt. Carmel', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Jackson Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}], 'overallOfficials': [{'name': 'Carol Lynn Berseth, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Kansas Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}