NCT00798382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

4 months

First QC Date

November 25, 2008

Last Update Submit

June 12, 2012

Conditions

Infant, Newborn

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.

    35 days

Secondary Outcomes (1)

  • Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age

    35 days

Study Arms (3)

1: Soy formula

EXPERIMENTAL

experimental soy formula #1

Other: soy protein formula

2: Soy Formula

ACTIVE COMPARATOR

Commercially available soy formula

Other: Commercially available soy formula

3: Soy formula

EXPERIMENTAL

experimental soy formula #2

Other: Soy formula experimental #2

Interventions

soy protein formulaOTHER

ad lib for 0-35 days of age

Also known as: experimental soy formula
1: Soy formula
Commercially available soy formulaOTHER

ad lib for 0-35 days of age

2: Soy Formula
Soy formula experimental #2OTHER

ad lib for 0-35 days of age

Also known as: Experimental soy formula
3: Soy formula

Eligibility Criteria

AgeUp to 8 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc

Plantation, Florida, 33324, United States

Location

SCORE Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

University of South Florida Health Pediatrics

Tampa, Florida, 33606, United States

Location

North Georgia Clinical Research

Dalton, Georgia, 30721, United States

Location

Medical Associates Clinic

Dubuque, Iowa, 52002, United States

Location

Kentucky Pediatric Research

Bardstown, Kentucky, 40004, United States

Location

PediaResearch, LLC

Owensboro, Kentucky, 42301, United States

Location

Midwest Children's Health Research Institute, LLC

Lincoln, Nebraska, 68504, United States

Location

Center for Human Nutrition

Omaha, Nebraska, 68105, United States

Location

Pediatric Associates of Mount Carmel, Inc

Cincinnati, Ohio, 45245, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Ohio Pediatric Research Association

Huber Heights, Ohio, 45424, United States

Location

Institute of Clinical Research, LLC

Mayfield Heights, Ohio, 44124, United States

Location

Primary Physician's Research, Inc

Pittsburgh, Pennsylvania, 15241, United States

Location

West Virginia University, Department of Pediatrics

Morgantown, West Virginia, 26506, United States

Location

Study Officials

  • John Lasekan, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 26, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(17)