Behavior of Infants Fed Formula Supplemented With Prebiotics
Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics
1 other identifier
interventional
59
1 country
11
Brief Summary
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
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
April 28, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2017
CompletedJune 19, 2017
June 1, 2017
1 year
April 28, 2016
June 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Fussiness
Parent questionnaires
Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding
Secondary Outcomes (4)
Fussiness
Baseline to Day 29
Hours of Daily Crying
Baseline to Day 29
Gastrointestinal Tolerance
Baseline to Day 29
Stool Pattern
Baseline to Day 29
Study Arms (1)
Infant formula supplemented with prebiotics
EXPERIMENTALinfant formula powder, feed ad libitum
Interventions
Sole source nutrition
Eligibility Criteria
You may qualify if:
- Subject is judged to be in good health.
- Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
- Infant was identified by parents as very fussy or extremely fussy.
- Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
You may not qualify if:
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
- Subject participates in another study that has not been approved as a concomitant study.
- Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
- Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
- Mother intends to use a combination of breast and formula feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (11)
Southeastern Pediatric Associates
Dothan, Alabama, 36305, United States
Pensacola Research Consultants, Inc
Pensacola, Florida, 32503, United States
Score Physician Alliance, LLC
St. Petersburg, Florida, 33710, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47713, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510, United States
Aventiv Research
Grove City, Ohio, 43123, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Southwest Children's Research Associates, P.A.
San Antonio, Texas, 78229, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marlene Borschel, PhD, RD, LD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2016
First Posted
May 2, 2016
Study Start
May 1, 2016
Primary Completion
May 2, 2017
Study Completion
May 2, 2017
Last Updated
June 19, 2017
Record last verified: 2017-06