NCT01897922

Brief Summary

This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

22 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

July 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

July 3, 2013

Last Update Submit

September 24, 2015

Conditions

Growth of Term Infants

Outcome Measures

Primary Outcomes (1)

  • Body weight measured at each study visit

    3.5 months

Secondary Outcomes (7)

  • Recall of infant formula intake at each study visit

    3.5 months

  • Body length measured at each study visit

    3.5 months

  • Recall of stool consistency measured at each study visit

    3.5 months

  • Medically-confirmed adverse events collected throughout the study period

    3.5 months

  • Parental Study Product Assessment Questionnaire completed at Study Visit 2

    once

  • +2 more secondary outcomes

Study Arms (2)

Marketed routine infant formula

ACTIVE COMPARATOR
Other: Control: Marketed routine infant formula

Infant formula containing a probiotic source

EXPERIMENTAL
Other: An investigational infant formula containing a probiotic source

Interventions

An investigational infant formula containing a probiotic sourceOTHER
Infant formula containing a probiotic source
Control: Marketed routine infant formulaOTHER
Marketed routine infant formula

Eligibility Criteria

Age12 Days - 16 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Singleton, 12-16 days of age at randomization
  • Term infant with birth weight of a minimum of 2500 grams
  • Solely formula fed
  • Signed Informed Consent and Protected Health Information

You may not qualify if:

  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or formula intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

Location

Greenvale Pediatrics Hoover

Birmingham, Alabama, 35244, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Pediatrics East - Alabama Clinical Therapeutics

Pinson, Alabama, 35126, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Arkkansas Pediatric Clinic

Little Rock, Arkansas, 72205, United States

Location

Norwich Pediatric Group, P.C.

Norwich, Connecticut, 06360, United States

Location

Children's Research, LLC

Altamonte Springs, Florida, 32701, United States

Location

Children's Medical Associations

Plantation, Florida, 33324, United States

Location

Deaconess Clinical Research

Evansville, Indiana, 47713, United States

Location

Owensboro Pediatrics

Owensboro, Kentucky, 42303, United States

Location

Woburn Pediatic Associates

Woburn, Massachusetts, 01801, United States

Location

Cary Pediatric Center, P.A.

Cary, North Carolina, 27518, United States

Location

Capital Pediatrics & Adolescent Center

Raleigh, North Carolina, 27609, United States

Location

Pediatric Associates of Mt. Carmel, Inc

Cincinnati, Ohio, 45245, United States

Location

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, 45014, United States

Location

Parma Pediatrics, Inc

Parma, Ohio, 44129, United States

Location

UHMP Comprehensive Pediatrics

Westlake, Ohio, 44145, United States

Location

The Jackson Clinic - North Jackson

Jackson, Tennessee, 38305, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Austin Diagnostic Clinic

Austin, Texas, 78749, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Related Publications (1)

  • Berseth CL, Yeiser M, Harris CL, Kinnaman JN, Lappin V, Wampler JL, Zhuang W, Vanderhoof J. Infant formula with added Lacticaseibacillus rhamnosus GG supported adequate growth and was well tolerated in healthy term infants: a randomized controlled trial. Front Pediatr. 2024 Oct 23;12:1456607. doi: 10.3389/fped.2024.1456607. eCollection 2024.

    PMID: 39507493DERIVED

Study Officials

  • Carol Lynn Berseth, M.D.

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

US(22)