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Tolerance of Healthy Term Infants Fed Infant Formulas #4

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ClinicalTrials.gov Identifier: NCT01155414
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 1, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Term Infants Other: Hydrolysate based infant formula Other: Investigational Infant Formula A Other: Investigational Infant Formula B Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance of Healthy Term Infants Fed Infant Formulas
Study Start Date : March 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. GI tolerance via stool consistency [ Time Frame: 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155414


Locations
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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
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Study Chair: Marlene Borschel, PhD Abbott Nutrition
More Information
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01155414    
Other Study ID Numbers: AK75
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: November 2010