Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

Phase 2

Completed

• Conditions: Infant, Newborn
• Interventions: Other: soy protein formula; Other: Commercially available soy formula; Other: Soy formula experimental #2

• Registration Number: NCT00798382
• Lead Sponsor: Abbott Nutrition

Brief Summary

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Study Start: 2008-12
• Primary Completion: 2009-04
• Study Completion: 2009-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Infant is judged to be in good health.
• Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
• Infant's birth weight was > 2490 g (~5 lb 8 oz).
• Infant is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
• Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

Exclusion Criteria

• An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Infant has been treated with antibiotics.
• Infant has received probiotics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Soy formula	soy protein formula	experimental soy formula #1
2: Soy Formula	Commercially available soy formula	Commercially available soy formula
3: Soy formula	Soy formula experimental #2	experimental soy formula #2

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.	35 days

Secondary Outcome Measures

Name	Time	Method
Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age	35 days

Trial Locations

Locations (17)

All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc; 🇺🇸 Plantation, Florida, United States

SCORE Physician Alliance, LLC; 🇺🇸 St. Petersburg, Florida, United States

Kentucky Pediatric Research; 🇺🇸 Bardstown, Kentucky, United States

PediaResearch, LLC; 🇺🇸 Owensboro, Kentucky, United States

Midwest Children's Health Research Institute, LLC; 🇺🇸 Lincoln, Nebraska, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Primary Physician's Research, Inc; 🇺🇸 Pittsburgh, Pennsylvania, United States

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States

North Georgia Clinical Research; 🇺🇸 Dalton, Georgia, United States

Medical Associates Clinic; 🇺🇸 Dubuque, Iowa, United States

Dayton Clinical Research; 🇺🇸 Dayton, Ohio, United States

Ohio Pediatric Research Association; 🇺🇸 Huber Heights, Ohio, United States

Institute of Clinical Research, LLC; 🇺🇸 Mayfield Heights, Ohio, United States

West Virginia University, Department of Pediatrics; 🇺🇸 Morgantown, West Virginia, United States

University of South Florida Health Pediatrics; 🇺🇸 Tampa, Florida, United States

Center for Human Nutrition; 🇺🇸 Omaha, Nebraska, United States

Pediatric Associates of Mount Carmel, Inc; 🇺🇸 Cincinnati, Ohio, United States