Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-12 @ 11:27 PM
Study NCT ID:
NCT03710551
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Happy Smooth Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool Consistency Score', 'timeFrame': 'Study Day 57, corresponding to infant age of 78-85 days', 'description': "3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days.\n\nA validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools.\n\nStool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate.\n\nthe percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period."}], 'secondaryOutcomes': [{'measure': 'GI Tolerance', 'timeFrame': 'which corresponds to infant age of 21-28, 43-50, and 78-85 days.', 'description': "Infant Gastrointestinal Symptom Questionnaire (IGSQ)\n\nOverall GI symptom burden will be measured with the IGSQ-13 questionnaire. The IGSQ-13 is an interviewer-administered questionnaire which measures how well the infant tolerates his/her feedings from the parent's/caregiver's perspective. The questionnaire is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fuzziness, and flatulence and summed to calculate an index score."}, {'measure': 'Changes in Weight from baseline to 57 days', 'timeFrame': 'Study Day 57, corresponding to infant age of 78-85 days', 'description': 'weight (kg)'}, {'measure': 'Changes in Length from baseline to 57 days', 'timeFrame': 'Study Day 57, corresponding to infant age of 78-85 days', 'description': 'length (cm)'}, {'measure': 'Changes in Head Circumference from baseline to 57 days', 'timeFrame': 'Study Day 57, corresponding to infant age of 78-85 days', 'description': 'head circumference (cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant Term Birth']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.', 'detailedDescription': 'Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '21 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed Consent\n* Infants whose parents/LAR have reached the legal age of majority in the Philippines\n* Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol\n* Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study\n* Healthy term, singleton infant at birth\n* Between 21 to 28 days post-natal age at enrollment visit\n* Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts\n* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment\n\nExclusion Criteria:\n\n* Infants with conditions requiring infant feedings other than those specified in the protocol\n* Infants receiving complementary foods or liquids\n* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results\n* Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results'}, 'identificationModule': {'nctId': 'NCT03710551', 'briefTitle': 'Happy Smooth Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '16.28.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Infant Formula', 'description': 'Experimental Infant Formula with a new fat blend plus L. reuteri', 'interventionNames': ['Other: Experimental Infant Formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Infant Formula', 'description': 'Standard bovine milk-based infant formula.', 'interventionNames': ['Other: Standard Infant Formula']}], 'interventions': [{'name': 'Experimental Infant Formula', 'type': 'OTHER', 'description': 'Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum', 'armGroupLabels': ['Experimental Infant Formula']}, {'name': 'Standard Infant Formula', 'type': 'OTHER', 'description': 'Standard bovine milk-based infant formula, fed ad libitum', 'armGroupLabels': ['Standard Infant Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'Asian Hospital and Medical Center', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}], 'overallOfficials': [{'name': 'Elvira M Estorninos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}