NCT00503789

Brief Summary

Infants will be fed infant formula and stool characteristics assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable healthy

Geographic Reach
1 country

23 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

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 5, 2008

Status Verified

September 1, 2008

Enrollment Period

1.1 years

First QC Date

July 17, 2007

Last Update Submit

September 4, 2008

Conditions

Healthy

Keywords

Healthy infants

Outcome Measures

Primary Outcomes (1)

  • fecal bacteria analysis

    60 days

Secondary Outcomes (1)

  • Intake, tolerance, stool characteristics, anthropometrics

    60 days

Study Arms (3)

1

ACTIVE COMPARATOR

cow-milk based infant formula

Procedure: fecal bacteria analysis

2

EXPERIMENTAL

cow milk based infant formula with prebiotics

Procedure: fecal bacteria analysis

3

OTHER

human milk reference group

Procedure: fecal bacteria analysis

Interventions

fecal bacteria analysisPROCEDURE

ad lib feeding

123

Eligibility Criteria

Age21 Days - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy, term infants
  • days of age

You may not qualify if:

  • Infants with feeding difficulties
  • Use of antibiotics or steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Central Arkansas Pediatric Clinic

Benton, Arkansas, 72019, United States

Location

Arkansas Pediatrics of Conway

Conway, Arkansas, 22401, United States

Location

The Children's Clinic of Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

Altamonte Pediatric Associates

Altamonte Springs, Florida, 32701, United States

Location

Advocate Center for Pediatric Research

Park Ridge, Illinois, 60068, United States

Location

Internal Medicine and Pediatrics

Fishers, Indiana, 46038, United States

Location

East Washington Pediatrics

Indianapolis, Indiana, 46229, United States

Location

Children's Hospital of Iowa

Coralville, Iowa, 52241, United States

Location

University of Kansas Medical University

Kansas City, Kansas, 66160, United States

Location

PTCU/Children and Youth Project

Louisville, Kentucky, 40202, United States

Location

ACC Pediatric Research

Bossier City, Louisiana, 71111, United States

Location

ProMed Healthcare

Kalamazoo, Michigan, 49008, United States

Location

ProMed Pediatrics

Portage, Michigan, 49024, United States

Location

ProMed Physicians-Pediatrics

Richland, Michigan, 49083, United States

Location

The Center for Human Nutrition

Omaha, Nebraska, 68105, United States

Location

Winthrop Pediatric Associates

Mineola, New York, 11501, United States

Location

Cary Pediatric Center, P.A.

Cary, North Carolina, 27511, United States

Location

Pediatric Associates of Mt. Carmel, Inc.

Cincinnati, Ohio, 45245, United States

Location

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, 45014, United States

Location

Northeast Cincinnati Pediatric Assoc

Mason, Ohio, 45040, United States

Location

Red Lion Pediatrics

Philadelphia, Pennsylvania, 19114, United States

Location

Alpha Clinical Research

Clarksville, Tennessee, 37043, United States

Location

Austin Diagnostic Clinic

Austin, Texas, 78745, United States

Location

Related Publications (2)

  • Salminen S, Endo A, Isolauri E, Scalabrin D. Early Gut Colonization With Lactobacilli and Staphylococcus in Infants: The Hygiene Hypothesis Extended. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):80-6. doi: 10.1097/MPG.0000000000000925.

    PMID: 26230902DERIVED

  • Scalabrin DM, Mitmesser SH, Welling GW, Harris CL, Marunycz JD, Walker DC, Bos NA, Tolkko S, Salminen S, Vanderhoof JA. New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):343-52. doi: 10.1097/MPG.0b013e318237ed95.

    PMID: 21946836DERIVED

Study Officials

  • Deolinda Scalabrin, MD

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 5, 2008

Record last verified: 2008-09

Locations

US(23)