Tolerance of Healthy Term Infants Fed Infant Formulas #4
1 other identifier
interventional
168
1 country
10
Brief Summary
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
10 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
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 1, 2011
November 1, 2010
4 months
June 28, 2010
October 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
GI tolerance via stool consistency
28 days
Study Arms (3)
Investigational infant formula A
EXPERIMENTALInvestigational Protein Hydrolysate formula
Hydrolysate based Infant Formula
ACTIVE COMPARATORInvestigational Infant Formula B
EXPERIMENTALInvestigational Protein Hydrolysate Formula
Interventions
Investigational infant formula ad lib
Investigational infant formula ad lib
Eligibility Criteria
You may qualify if:
- Singleton full term birth in good health
- Birth weight was \> 2490 g.
- Between 0 and 8 days of age.
- Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
- 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 infant medical history and treatment with antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (10)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Alabama Clinical Therapeutics, LLC
Dothan, Alabama, 36305, United States
SCORE Physician Alliance
St. Petersburg, Florida, 33710, United States
University of Iowa
Coralville, Iowa, 52241, United States
Medical Associates Clinic, PC
Dubuque, Iowa, 52001, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio Pediatric Research Association
Huber Heights, Ohio, 45424, United States
Institute of Clinical Research
Mayfield Heights, Ohio, 44124, United States
Pediatric Clinical Research Office
Hershey, Pennsylvania, 17033, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
Study Officials
- STUDY CHAIR
Marlene Borschel, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2010
First Posted
July 1, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 1, 2011
Record last verified: 2010-11