Clinical trial NCT00798382: Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
Official title: Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infant, Newborn
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 154
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
timeFrame: 35 days
Secondary outcomes:
measure: Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age
timeFrame: 35 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Plantation
country: United States
facility: All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
state: Florida
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health Pediatrics
state: Florida
city: Dalton
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Dubuque
country: United States
facility: Medical Associates Clinic
state: Iowa
city: Bardstown
country: United States
facility: Kentucky Pediatric Research
state: Kentucky
city: Owensboro
country: United States
facility: PediaResearch, LLC
state: Kentucky
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC
state: Nebraska
city: Omaha
country: United States
facility: Center for Human Nutrition
state: Nebraska
city: Cincinnati
country: United States
facility: Pediatric Associates of Mount Carmel, Inc
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research, LLC
state: Ohio
city: Pittsburgh
country: United States
facility: Primary Physician's Research, Inc
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University, Department of Pediatrics
state: West Virginia
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, PhD
role: STUDY_CHAIR
References: