Acceptance Of A Partially-Hydrolyzed Infant Formula
1 other identifier
interventional
100
1 country
11
Brief Summary
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 9, 2019
January 1, 2019
1.4 years
July 12, 2017
January 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Stool consistency measured by MJN stool consistency scale
14 days
Secondary Outcomes (5)
Stool frequency
14 days
Formula acceptance measured by intake diary
14 days
Formula gastrointestinal tolerance measured by diary
14 days
Bowel movement characteristics by diary
14 days
Medically confirmed adverse events throughout the study period
14 days
Study Arms (2)
Control
ACTIVE COMPARATORInvestigational
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Singleton 28-300 days of age at randomization
- Gestational age less than or equal to 35 weeks
- Receiving minimum 18oz infant formula in the 24hrs prior to randomization
- History of hard stools or stooling difficulty
- Signed informed consent and protected health information
You may not qualify if:
- Current diagnosis of cow's milk protein allergy or intolerance
- Use of extensively hydrolyzed or amino acid formula at randomization
- Any abdominal or gastrointestinal surgery prior to randomization
- History of underlying metabolic or chronic disease or congenital malformation
- Organic causes of constipation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Birmingham Pediatric Associates
Birmingham, Alabama, 35205, United States
Southeastern Pediatric Associates
Dothan, Alabama, 36305, United States
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Deaconess Clinical Research
Evansville, Indiana, 47725, United States
Deaconess Clinic
Newburgh, Indiana, 47630, United States
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, 40004, United States
Owensboro Pediatrics
Owensboro, Kentucky, 42303, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Study Officials
- STUDY DIRECTOR
Steven Wu
Mead Johnson Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 21, 2017
Study Start
August 21, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
January 9, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share