NCT02405572

Brief Summary

Crossover study of 2 infant formulas

Trial Health

80
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable healthy

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

February 23, 2015

Last Update Submit

May 11, 2016

Conditions

Healthy

Keywords

formula-fedinfants

Outcome Measures

Primary Outcomes (1)

  • stool consistency

    caregivers will document on diary records

    2 weeks

Secondary Outcomes (6)

  • spit-up pattern

    2 weeks

  • formula intake

    2 weeks

  • adverse events

    2 weeks

  • stool pattern

    2 weeks

  • mood

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Formula 1

ACTIVE COMPARATOR

infant formula

Other: infant formula

Formula 2

ACTIVE COMPARATOR

infant formula

Other: infant formula

Interventions

infant formulaOTHER

infant formulas

Formula 1Formula 2

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborn infant
  • Full-term (\> 37 weeks gestation)
  • months (birth-56 days) of age on enrollment
  • Infant exclusively formula-fed for at least 2 days prior to enrollment
  • Having obtained his/her legal representative's informed consent

You may not qualify if:

  • Known or suspected cow-milk allergy
  • Congenital illness or malformation
  • Significant prenatal and/or postnatal disease
  • Currently participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pedia Research

Owensboro, Kentucky, 47630, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Rich Litov, PhD

    Pedia Research

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 23, 2015

First Posted

April 1, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(2)