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Clinical Trials/NCT04529759
NCT04529759
Completed
Not Applicable

Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides

Abbott Nutrition6 sites in 1 country108 target enrollmentSeptember 12, 2020
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ConditionsTolerance

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tolerance
Sponsor
Abbott Nutrition
Enrollment
108
Locations
6
Primary Endpoint
Mean rank stool consistency (MRSC)
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Registry
clinicaltrials.gov
Start Date
September 12, 2020
End Date
June 18, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Good health as determined from participant's medical history
  • •Singleton from a full-term birth with a gestational age of 37-42 weeks
  • •Birth weight was \> 2490 g (\~5 lbs. 8 oz.)
  • •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, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices 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

  • •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
  • •Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
  • •Participant is enrolled in another study that has not been approved as a concomitant study

Outcomes

Primary Outcomes

Mean rank stool consistency (MRSC)

Time Frame: Study Day 1 to 28 Days of Age

Parent Completed Diary

Secondary Outcomes

  • Weight(14 to 119 Days of Age)
  • Gastrointestinal tolerance(14 to 119 Days of Age)
  • Length(14 to 119 Days of Age)
  • Head Circumference(14 to 119 Days of Age)

Study Sites (6)

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