NCT00543673

Brief Summary

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2 healthy

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2 healthy

Geographic Reach
1 country

10 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

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 4, 2008

Status Verified

June 1, 2008

Enrollment Period

8 months

First QC Date

October 5, 2007

Last Update Submit

July 3, 2008

Conditions

Healthy

Keywords

Healthy term infants

Outcome Measures

Primary Outcomes (1)

  • Mean rank stool consistency (MRSC)

    Study Day 1 to Visit 3

Secondary Outcomes (1)

  • MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting

    4 months

Study Arms (4)

Milk based formula A

EXPERIMENTAL

Experimental milk based infant formula

Other: Milk based formula A

Standard formula

ACTIVE COMPARATOR

standard milk based infant formula

Other: #2 Standard formula

Reference

OTHER

Human milk

Other: #3 Human Milk

Milk based formula C

EXPERIMENTAL

Experimental milk based infant formula

Other: Milk based formula C

Interventions

Milk based formula AOTHER

feed as per HCP directions

Also known as: AN0710A
Milk based formula A
#2 Standard formulaOTHER

Feed as per HCP directions

Also known as: AN0710B
Standard formula
#3 Human MilkOTHER

Feed as per HCP directions

Also known as: Human Milk
Reference
Milk based formula COTHER

Feed as per HCP direction

Also known as: AN0710C
Milk based formula C

Eligibility Criteria

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

You may qualify if:

  • judged to be in good health.
  • singleton from a full term birth with a gestational age of 37-42 weeks
  • birth weight was \> 2490 g (\~5 lbs 8 oz)
  • between 0 and 8 days of age at enrollment.
  • Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

You may not qualify if:

  • An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
  • Infant has been treated with antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The Pediatric Clinic

North Little Rock, Arkansas, 72117, United States

Location

USF

Tampa, Florida, 33606, United States

Location

North Georgia Clinical Research, White's Pediatrics

Dalton, Georgia, 30721, United States

Location

Medical Associates Clinic

Dubuque, Iowa, 52001, United States

Location

Midwest Children's Health Research Institute, LLC

Lincoln, Nebraska, 68505, United States

Location

The Childrens Medical Group LLC

Poughkeepsie, New York, 12603, United States

Location

Levine Childrens Hospital

Charlotte, North Carolina, 28207, United States

Location

Ohio Pediatrics, Inc.

Huber Heights, Ohio, 45424, United States

Location

Institute of Clinical Research

Mayfield Heights, Ohio, 44124, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 78508, United States

Location

Related Publications (1)

  • Williams T, Choe Y, Price P, Katz G, Suarez F, Paule C, Mackey A. Tolerance of formulas containing prebiotics in healthy, term infants. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):653-8. doi: 10.1097/MPG.0000000000000513.

    PMID: 25061716DERIVED

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Timberly A. Williams, M.S.

    Abbott Nutrition, Abbott Laboratories

    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

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 15, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

July 4, 2008

Record last verified: 2008-06

Locations

US(10)