NCT03884309

Brief Summary

This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

March 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

March 18, 2019

Last Update Submit

January 31, 2020

Conditions

Protein Intolerance

Outcome Measures

Primary Outcomes (1)

  • Weight for Age

    Change in weight for age z-score

    Study Day 1 to Study Day 60

Secondary Outcomes (3)

  • Gastrointestinal Tolerance

    Study Day 1 to Study Day 60

  • Length

    Study Day 1 to Study Day 60

  • Head Circumference

    Study Day 1 to Study Day 60

Study Arms (1)

Experimental Hydrolyzed Protein Infant Formula

EXPERIMENTAL

hydrolyzed protein infant formula powder in cans

Other: Experimental Hydrolyzed Protein Infant Formula

Interventions

Experimental Hydrolyzed Protein Infant FormulaOTHER

fed ad libitum

Experimental Hydrolyzed Protein Infant Formula

Eligibility Criteria

AgeUp to 60 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
  • Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
  • 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
  • Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) 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 growth, and/or development.
  • Participant is receiving oral or inhaled steroids.
  • Participant participates in another study that has not been approved as a concomitant study.
  • Participant has an allergy or intolerance to any ingredient in the study product.
  • Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Paramount Research Solutions

College Park, Georgia, 30349, United States

Location

Michael W. Simon, M.D., PSC

Nicholasville, Kentucky, 40356, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68522, United States

Location

Memphis & Shelby County Pediatric Group

Memphis, Tennessee, 38116, United States

Location

Ventavia Research Group, LLC

Houston, Texas, 77008, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Study Officials

  • Barbara Marriage, PhD, RD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 21, 2019

Study Start

March 25, 2019

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

US(6)