The Effects on Growth of a Non-Routine Infant Formula

NCT ID: NCT00655720

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

infant formula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

infant formula

Intervention Type OTHER

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

2

Group Type EXPERIMENTAL

infant formula

Intervention Type OTHER

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

3

Group Type EXPERIMENTAL

infant formula

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

infant formula

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

no other names for any of the intervention arms

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Term infant
* Solely formula fed
* 14 days of age

Exclusion Criteria

* History of underlying disease
* Evidence of formula intolerance
* Current illness
Minimum Eligible Age

12 Days

Maximum Eligible Age

16 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mead Johnson

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deolinda Scalabrin, MD

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19264721 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3369-5

Identifier Type: -

Identifier Source: secondary_id

3369-5

Identifier Type: -

Identifier Source: org_study_id