Tolerance of Healthy Term Infants Fed Infant Formulas

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

Completed

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Key information

Conditions

Infant, Newborn

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Global Clinical Investigation, Aventura, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

milk protein formulas, varying carbohydrate/protein sources

Other

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

Primary outcomes

Gastrointestinal tolerance

Time frame: 0-8 days of age until 28 days of age

Secondary outcomes

GI and intake parameters

Time frame: 0-8 to 28 days of age

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jun 26, 2008
Registry last updated: Jan 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed