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Growth and Safety of a Low Lactose Milk-Based Infant Formula

An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01497314
Enrollment
85
Registered
2011-12-22
Start date
2011-12-31
Completion date
2013-03-31
Last updated
2013-05-15

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

Conditions

Growth, Healthy Term Infants

Keywords

healthy term infants, growth, infant formula

Brief summary

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Detailed description

Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Interventions

OTHERLow Lactose Infant Formula

Low Lactose Infant Formula

Sponsors

Perrigo Nutritionals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes

Inclusion criteria

* healthy term infants * birth weight 2500 - 4500 g * singleton birth * 37 - 42 weeks gestation

Exclusion criteria

* clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history * receiving medications other than vitamins

Design outcomes

Primary

MeasureTime frame
Weight16 weeks

Secondary

MeasureTime frameDescription
Length gain16 weeks—
Occipital Head Circumference16 weeks—
Acceptability and Tolerability16 weeksAssessed by digestive tolerance; general health and well-being; adverse events; concomitant medications

Countries

United States

Outcome results

None listed

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