Clinical trial NCT00977964: Tolerance of Healthy Term Infants Fed Infant Formulas #3
Official title: Tolerance of Healthy Term Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Tolerance
Keywords: Infant
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 270
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.


Eligibility criteria: Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth.
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.
* Infant is between 0 and 8 days of age at enrollment.
* Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

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: The primary variable is Gastrointestinal tolerance.
timeFrame: 1-28 days of age
Secondary outcomes:
measure: The secondary variables are additional measures of GI tolerance and parental feedback.
timeFrame: 1-28 days of age
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
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
state: Florida
city: Dalton
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Indianapolis
country: United States
facility: Northpoint Pediatrics, LLC
state: Indiana
city: Dubuque
country: United States
facility: Medical Associates Clinic, PC
state: Iowa
city: Bardstown
country: United States
facility: Kentucky Pediatric / Adult Research
state: Kentucky
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, Inc.
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Spokane
country: United States
facility: Rockwood Clinic North - Pediatrics
state: Washington
Study officials:
affiliation: Alabama Clinical Therapeutics, LLC
name: Caude T Ashley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: USF Department of Pediatrics
name: Terri L Ashmeade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Discovery Clinical Research, Inc.
name: Jay Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rockwood Clinic
name: Timothy Crum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Georgia Clinical Research, White's Pediatrics
name: Cole Ezeoke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MetroHealth Medical Center
name: Sharon Groh-Wargo, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Clinical Research, LLC
name: James Guerrieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kentucky Pediatric Research
name: James Hedrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SCORE Physician Alliance, LLC
name: Jeffrey Hirschfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Associates Clinic, PC
name: Kevin Mullen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Associates of Mount Carmel, Inc.
name: Chris Peltier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dayton Clinical Research
name: Martin J Schear, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio Pediatric Research Association
name: Julie Shepard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarah Cannon Research Institute, LLC
name: William Stepp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northpoint Pediatrics
name: L Louise Tetrick, MD
role: PRINCIPAL_INVESTIGATOR
References: