Tolerance of Healthy Term Infants Fed Infant Formulas #4

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01155414
First received: June 28, 2010
Last updated: October 31, 2011
Last verified: November 2010
  Purpose

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.


Condition Intervention Phase
Healthy Term Infants
Other: Hydrolysate based infant formula
Other: Investigational Infant Formula A
Other: Investigational Infant Formula B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance of Healthy Term Infants Fed Infant Formulas

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • GI tolerance via stool consistency [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational infant formula A
Investigational Protein Hydrolysate formula
Other: Investigational Infant Formula A
Investigational infant formula ad lib
Active Comparator: Hydrolysate based Infant Formula Other: Hydrolysate based infant formula
Infant formula ad lib
Experimental: Investigational Infant Formula B
Investigational Protein Hydrolysate Formula
Other: Investigational Infant Formula B
Investigational infant formula ad lib

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton full term birth in good health
  • Birth weight was > 2490 g.
  • Between 0 and 8 days of age.
  • Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to 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, unless instructed otherwise by their healthcare professional.
  • 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.

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155414

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Alabama Clinical Therapeutics, LLC
Dothan, Alabama, United States, 36305
United States, Florida
SCORE Physician Alliance
St. Petersburg, Florida, United States, 33710
United States, Iowa
University of Iowa
Coralville, Iowa, United States, 52241
Medical Associates Clinic, PC
Dubuque, Iowa, United States, 52001
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio Pediatric Research Association
Huber Heights, Ohio, United States, 45424
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
United States, Pennsylvania
Pediatric Clinical Research Office
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
The Jackson Clinic, PA
Jackson, Tennessee, United States, 38305
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Marlene Borschel, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01155414     History of Changes
Other Study ID Numbers: AK75
Study First Received: June 28, 2010
Last Updated: October 31, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014