The Effects on Growth of a Non-Routine Infant Formula

The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00655720

Enrollment

293

Registered

2008-04-10

Start date

2006-03-31

Completion date

2007-05-31

Last updated

2008-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth

Keywords

infant formula

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

Interventions

OTHERinfant formula

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Days to 16 Days

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Growth (weight)	106 days

Secondary

Measure	Time frame
Tolerance	106 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026