Clinical trial NCT00503789: The Effect of Infant Feeding on Stool Characteristics
Official title: The Effect of Infant Feeding on Stool Characteristics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy infants
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2007-07-19
Enrollment: 280
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Infants will be fed infant formula and stool characteristics assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy, term infants
* 21-30 days of age

Exclusion Criteria:

* Infants with feeding difficulties
* Use of antibiotics or steroids

Primary outcomes:
measure: fecal bacteria analysis
timeFrame: 60 days
Secondary outcomes:
measure: Intake, tolerance, stool characteristics, anthropometrics
timeFrame: 60 days
Other outcomes:
Locations:
city: Benton
country: United States
facility: Central Arkansas Pediatric Clinic
state: Arkansas
city: Conway
country: United States
facility: Arkansas Pediatrics of Conway
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro
state: Arkansas
city: Altamonte Springs
country: United States
facility: Altamonte Pediatric Associates
state: Florida
city: Park Ridge
country: United States
facility: Advocate Center for Pediatric Research
state: Illinois
city: Fishers
country: United States
facility: Internal Medicine and Pediatrics
state: Indiana
city: Indianapolis
country: United States
facility: East Washington Pediatrics
state: Indiana
city: Coralville
country: United States
facility: Children's Hospital of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical University
state: Kansas
city: Louisville
country: United States
facility: PTCU/Children and Youth Project
state: Kentucky
city: Bossier City
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Kalamazoo
country: United States
facility: ProMed Healthcare
state: Michigan
city: Portage
country: United States
facility: ProMed Pediatrics
state: Michigan
city: Richland
country: United States
facility: ProMed Physicians-Pediatrics
state: Michigan
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Mineola
country: United States
facility: Winthrop Pediatric Associates
state: New York
city: Cary
country: United States
facility: Cary Pediatric Center, P.A.
state: North Carolina
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc.
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: Mason
country: United States
facility: Northeast Cincinnati Pediatric Assoc
state: Ohio
city: Philadelphia
country: United States
facility: Red Lion Pediatrics
state: Pennsylvania
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Austin Diagnostic Clinic
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Deolinda Scalabrin, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.