The Effect of Infant Feeding on Stool Characteristics

• Sponsor: Mead Johnson Nutrition (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00503789
• Collaborator: (none)
• Enrollment: 280
• Locations: 23
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Infants will be fed infant formula and stool characteristics assessed.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: fecal bacteria analysis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: The Effect of Infant Feeding on Stool Characteristics
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 cow-milk based infant formula	Procedure: fecal bacteria analysis; ad lib feeding
Experimental: 2 cow milk based infant formula with prebiotics	Procedure: fecal bacteria analysis; ad lib feeding
Other: 3 human milk reference group	Procedure: fecal bacteria analysis; ad lib feeding

Outcome Measures

Primary Outcome Measures

1. fecal bacteria analysis [60 days]

Secondary Outcome Measures

1. Intake, tolerance, stool characteristics, anthropometrics [60 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Days to 30 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy, term infants

• 21-30 days of age

Exclusion Criteria:

• Infants with feeding difficulties

• Use of antibiotics or steroids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas Pediatric Clinic	Benton	Arkansas	United States	72019
2	Arkansas Pediatrics of Conway	Conway	Arkansas	United States	22401
3	The Children's Clinic of Jonesboro	Jonesboro	Arkansas	United States	72401
4	Altamonte Pediatric Associates	Altamonte Springs	Florida	United States	32701
5	Advocate Center for Pediatric Research	Park Ridge	Illinois	United States	60068
6	Internal Medicine and Pediatrics	Fishers	Indiana	United States	46038
7	East Washington Pediatrics	Indianapolis	Indiana	United States	46229
8	Children's Hospital of Iowa	Coralville	Iowa	United States	52241
9	University of Kansas Medical University	Kansas City	Kansas	United States	66160
10	PTCU/Children and Youth Project	Louisville	Kentucky	United States	40202
11	ACC Pediatric Research	Bossier City	Louisiana	United States	71111
12	ProMed Healthcare	Kalamazoo	Michigan	United States	49008
13	ProMed Pediatrics	Portage	Michigan	United States	49024
14	ProMed Physicians-Pediatrics	Richland	Michigan	United States	49083
15	The Center for Human Nutrition	Omaha	Nebraska	United States	68105
16	Winthrop Pediatric Associates	Mineola	New York	United States	11501
17	Cary Pediatric Center, P.A.	Cary	North Carolina	United States	27511
18	Pediatric Associates of Mt. Carmel, Inc.	Cincinnati	Ohio	United States	45245
19	Pediatric Associates of Fairfield, Inc.	Fairfield	Ohio	United States	45014
20	Northeast Cincinnati Pediatric Assoc	Mason	Ohio	United States	45040
21	Red Lion Pediatrics	Philadelphia	Pennsylvania	United States	19114
22	Alpha Clinical Research	Clarksville	Tennessee	United States	37043
23	Austin Diagnostic Clinic	Austin	Texas	United States	78745

Sponsors and Collaborators

• Mead Johnson Nutrition

Investigators

• Study Director: Deolinda Scalabrin, MD, Mead Johnson Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00503789
• Other Study ID Numbers: 33715
• First Posted: Jul 19, 2007
• Last Update Posted: Sep 5, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Healthy infants

Study Results

No Results Posted as of Sep 5, 2008