Tolerance of Healthy Infants Fed Infant Formulas
1 other identifier
interventional
126
1 country
6
Brief Summary
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
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 Apr 2015
Shorter than P25 for not_applicable
6 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
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 12, 2016
January 1, 2016
5 months
March 16, 2015
January 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.
Change from Study Day 1 to Study Day 15
Secondary Outcomes (6)
Mean Percentage of stools representing each stool consistency and color using parent reported diaries
Change from Study Day 1 to Study Day 15
Mean predominant stool consistency and color measured using parent reported diaries
Change from Study Day 1 to Study Day 15
Average number of stools per day measured using parent reported diaries
Change from Study Day 1 to Study Day 15
Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.
Change from Study Day 1 to Study Day 15
Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires
Change from Study Day 1 to Study Day 15
- +1 more secondary outcomes
Study Arms (3)
Phase 1-Arm 1 Infant Formula
EXPERIMENTALMilk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum.
Phase 2- Arm 2 Infant Formula
ACTIVE COMPARATORMilk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum.
Phase 2- Arm 3 Infant Formula
EXPERIMENTALMilk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum.
Interventions
Eligibility Criteria
You may qualify if:
- Singleton from a full term birth with a gestational age of 37-42 weeks.
- Birth weight was \> 2490 g (\~5 lbs 8 oz).
- Age between 0 and 30 days at enrollment.
- Agreement to discontinue the use of medications (including over the counter \[OTC\], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
- Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
- Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
- Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
You may not qualify if:
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant treated with antibiotics.
- Participation in another study that has not been approved as a concomitant study by AN.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (6)
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, 85712, United States
SCORE Physician Alliance LLC
St. Petersburg, Florida, 33710, United States
White Oak Family Physicians DBA/Asheboro Research Associates
Asheboro, North Carolina, 27203, United States
Institute of Clinical Research, LLC
Mayfield Heights, Ohio, 44124, United States
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130, United States
Tanner Memorial Clinic
Layton, Utah, 84041, United States
Study Officials
- STUDY CHAIR
Marlene Borschel, PhD, RD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 27, 2015
Study Start
April 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
January 12, 2016
Record last verified: 2016-01