Tolerance of Healthy Term Infants Fed Infant Formulas #3

Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Conditions

• Gastrointestinal Tolerance

Interventions

OTHER

Experimental milk protein infant formula Process A

ad lib for 1-8 days of age until 28 days of age

OTHER

Experimental milk protein infant formula Process B

ad lib from 1-8 days of age until 28 days of age

OTHER

Experimental milk protein infant formula Process C

ad lib from 1-8 days of age to 28 days of age

OTHER

Experimental milk protein infant formula Process D

ad lib from 1-8 days of age until 28 days of age

OTHER

Experimental milk protein infant formula Process E

ad lib from 1-8 days of age until 28 days of age

OTHER

Experimental milk protein infant formula Process F

ad lib from 1-8 days of age until 28 days of age

Sponsors & Collaborators

• Abbott Nutrition

  lead INDUSTRY

Principal Investigators

• Caude T Ashley, MD · Alabama Clinical Therapeutics, LLC

• Terri L Ashmeade, MD · USF Department of Pediatrics

• Jay Cohen, MD · Discovery Clinical Research, Inc.

• Timothy Crum, MD · Rockwood Clinic

• Cole Ezeoke, MD · North Georgia Clinical Research, White's Pediatrics

• Sharon Groh-Wargo, PhD, RD, LD · MetroHealth Medical Center

• James Guerrieri, MD · Institute of Clinical Research, LLC

• James Hedrick, MD · Kentucky Pediatric Research

• Jeffrey Hirschfield, MD · SCORE Physician Alliance, LLC

• Kevin Mullen, MD · Medical Associates Clinic, PC

• Chris Peltier, MD · Pediatric Associates of Mount Carmel, Inc.

• Martin J Schear, MD · Dayton Clinical Research

• Julie Shepard, MD · Ohio Pediatric Research Association

• William Stepp, MD · Sarah Cannon Research Institute, LLC

• L Louise Tetrick, MD · Northpoint Pediatrics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

8 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2010-01-31

Completion

2010-01-31

Countries

• United States

Study Locations