NCT04529759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

September 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

August 25, 2020

Last Update Submit

July 14, 2021

Conditions

Tolerance

Outcome Measures

Primary Outcomes (1)

  • Mean rank stool consistency (MRSC)

    Parent Completed Diary

    Study Day 1 to 28 Days of Age

Secondary Outcomes (4)

  • 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

Other Outcomes (8)

  • Infant Stool Characteristics

    Study Day 1 to 119 Days of Age

  • Study Product Intake

    Study Day 1 to 119 Days of Age

  • Infant and Household Characteristics

    Study Day 1 to 119 Days of Age

  • +5 more other outcomes

Study Arms (2)

Control Infant Formula

ACTIVE COMPARATOR

Feed ad libitum

Other: Control Infant Formula

Experimental Infant Formula

EXPERIMENTAL

Feed ad libitum

Other: Experimental Infant Formula

Interventions

Control Infant FormulaOTHER

Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide

Control Infant Formula
Experimental Infant FormulaOTHER

Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend

Experimental Infant Formula

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

PAS Research, LLC

Tampa, Florida, 33613, United States

Location

Springs Medical Research

Owensboro, Kentucky, 43203, United States

Location

Institute of Clinical Research

Mentor, Ohio, 44060, United States

Location

The Cleveland Pediatric Research Center, LLC

Westlake, Ohio, 44145, United States

Location

Midsouth Center for Clinical Research

Memphis, Tennessee, 38116, United States

Location

Study Officials

  • John Lasekan, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

September 12, 2020

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(6)