Tolerance of Infants Fed a Hydrolysate Formula
1 other identifier
interventional
51
1 country
5
Brief Summary
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
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 Aug 2018
Shorter than P25 for not_applicable
5 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 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedDecember 19, 2018
December 1, 2018
3 months
July 13, 2018
December 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Stool Characteristics
Parent completed diary
Study Day 1 - Study Day 21
Secondary Outcomes (3)
Formula Intake
Study Day 1 - Study Day 21
Weight
Study Day 1 - Study Day 21
Length
Study Day 1 - Study Day 21
Study Arms (2)
Hydrolysate Infant Formula 1
ACTIVE COMPARATORReady to feed infant formula in can
Hydrolysate Infant Formula 2
EXPERIMENTALReady to feed infant formula in bottle
Interventions
Eligibility Criteria
You may qualify if:
- Subject is judged to be in good health
- Singleton from a full-term birth
- Birth weight was \> or = to 2490 g
- Between 0 and 14 days of age at enrollment
- Parent(s) confirm their intention to feed their infant the assigned 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
- Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)
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, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Subject participates in another study that has not been approved as a concomitant study
- Subject has an allergy or intolerance to any ingredient in the study product
- Subject has been treated with antibiotics within 2 weeks prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (5)
Watching Over Mothers and Babies
Tucson, Arizona, 85712, United States
Springs Medical Research
Owensboro, Kentucky, 42303, United States
The Cleveland Pediatric Research Center, LLC
Cleveland, Ohio, 44130, United States
Institute of Clinical Research, LLC
Mentor, Ohio, 44060, United States
Midsouth Center for Clinical Research
Memphis, Tennessee, 38116, United States
Study Officials
- STUDY CHAIR
Courtney Allgeier, MS, RD, LD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2018
First Posted
August 14, 2018
Study Start
August 28, 2018
Primary Completion
November 23, 2018
Study Completion
November 23, 2018
Last Updated
December 19, 2018
Record last verified: 2018-12