Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

Infant, Newborn Clinical Trial

Official title:

Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798382
• Other study ID #: AK54
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 25, 2008
• Last updated: June 12, 2012
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2012
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Newborn

Intervention

Other:
• soy protein formula
ad lib for 0-35 days of age
• Commercially available soy formula
ad lib for 0-35 days of age
• Soy formula experimental #2
ad lib for 0-35 days of age

Locations

Country	Name	City	State
United States	Kentucky Pediatric Research	Bardstown	Kentucky
United States	Pediatric Associates of Mount Carmel, Inc	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	North Georgia Clinical Research	Dalton	Georgia
United States	Dayton Clinical Research	Dayton	Ohio
United States	Medical Associates Clinic	Dubuque	Iowa
United States	Ohio Pediatric Research Association	Huber Heights	Ohio
United States	Midwest Children's Health Research Institute, LLC	Lincoln	Nebraska
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	Institute of Clinical Research, LLC	Mayfield Heights	Ohio
United States	West Virginia University, Department of Pediatrics	Morgantown	West Virginia
United States	Center for Human Nutrition	Omaha	Nebraska
United States	PediaResearch, LLC	Owensboro	Kentucky
United States	Primary Physician's Research, Inc	Pittsburgh	Pennsylvania
United States	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	University of South Florida Health Pediatrics	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.		35 days	No
Secondary	Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age		35 days	No