Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula
NCT ID: NCT04934397
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
18 participants
INTERVENTIONAL
2021-07-08
2022-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Study Infant Formula
Feed ad libitum during study period
Study Infant Formula
Powdered partially hydrolyzed whey (WPH) based infant formula with oligosaccharides
Interventions
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Study Infant Formula
Powdered partially hydrolyzed whey (WPH) based infant formula with oligosaccharides
Eligibility Criteria
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Inclusion Criteria
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
* Participant's birth weight was \>= 2490 g (\~5 lbs. 8 oz.)
* Participant is identified by parents as very fussy or extremely fussy on current formula in the Baseline Tolerance Evaluation
* Participant is exclusively formula-fed at time of study entry and 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) of participants confirm their intention not to administer vitamin, mineral, human milk oligosaccharides (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
Exclusion Criteria
* Participant is taking and plans to continue taking 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.
* Participant participates in another study that has not been approved as a concomitant study.
* Participant has been fed a formula containing greater than two HMOs prior to study enrollment.
* Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to enrollment and/or extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
* Participant has an allergy or intolerance to any ingredient in the study product
* Participant has been treated with antibiotics within 7 days prior to enrollment
7 Days
65 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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John Lasekan, PhD, MS, MBA, CCRP
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Southeastern Pediatric Associates
Dothan, Alabama, United States
ASCLEPES Research Centers
Spring Hill, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
MedPharmics
Covington, Louisiana, United States
Alivation Research
Lincoln, Nebraska, United States
ClinOhio Research Services
Columbus, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Institute of Clinical Research
Mentor, Ohio, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, United States
Midsouth Center for Clinical Research
Memphis, Tennessee, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Clear Lake Specialties
Webster, Texas, United States
Countries
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Other Identifiers
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AL42
Identifier Type: -
Identifier Source: org_study_id
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