NCT00655720

Brief Summary

A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics

Trial Health

100
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

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

March 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

1.2 years

First QC Date

March 28, 2008

Last Update Submit

April 10, 2008

Conditions

Growth

Keywords

infant formula

Outcome Measures

Primary Outcomes (1)

  • Growth (weight)

    106 days

Secondary Outcomes (1)

  • Tolerance

    106 days

Study Arms (3)

1

ACTIVE COMPARATOR
Other: infant formula

2

EXPERIMENTAL
Other: infant formula

3

EXPERIMENTAL
Other: infant formula

Interventions

infant formulaOTHER

1. hydrolyzed infant formula without probiotics 2. hydrolyzed infant formula with probiotics 3. hydrolyzed infant formula with probiotics

Also known as: no other names for any of the intervention arms
123

Eligibility Criteria

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

You may qualify if:

  • Term infant
  • Solely formula fed
  • days of age

You may not qualify if:

  • History of underlying disease
  • Evidence of formula intolerance
  • Current illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Scalabrin DM, Johnston WH, Hoffman DR, P'Pool VL, Harris CL, Mitmesser SH. Growth and tolerance of healthy term infants receiving hydrolyzed infant formulas supplemented with Lactobacillus rhamnosus GG: randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2009 Sep;48(7):734-44. doi: 10.1177/0009922809332682. Epub 2009 Mar 4.

    PMID: 19264721DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Deolinda Scalabrin, MD

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 10, 2008

Study Start

March 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 15, 2008

Record last verified: 2008-04