Tolerance of Healthy Term Infants Fed Infant Formulas

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00705562

Enrollment

190

Registered

2008-06-26

Start date

2008-06-30

Completion date

2008-12-31

Last updated

2009-01-05

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

Conditions

Infant, Newborn

Brief summary

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Interventions

OTHERmilk protein formulas, varying carbohydrate/protein sources

ad lib for 0-8 days of age until 28 days of age

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 8 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy, term infants; singleton birth; 37-42 weeks of age; \>2490gms at birth; 0-8 days of age

Exclusion criteria

* medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

Design outcomes

Primary

Measure	Time frame
Gastrointestinal tolerance	0-8 days of age until 28 days of age

Secondary

Measure	Time frame
GI and intake parameters	0-8 to 28 days of age

Countries

United States

Outcome results

None listed

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