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Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884309
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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Brief Summary:
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

Condition or disease Intervention/treatment Phase
Protein Intolerance Other: Experimental Hydrolyzed Protein Infant Formula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : January 7, 2020
Actual Study Completion Date : January 7, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Hydrolyzed Protein Infant Formula
hydrolyzed protein infant formula powder in cans
 Other: Experimental Hydrolyzed Protein Infant Formula
fed ad libitum


Outcome Measures
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Primary Outcome Measures :
  1. Weight for Age [ Time Frame: Study Day 1 to Study Day 60 ]
    Change in weight for age z-score


Secondary Outcome Measures :
  1. Gastrointestinal Tolerance [ Time Frame: Study Day 1 to Study Day 60 ]
    Parent completed diary questions

  2. Length [ Time Frame: Study Day 1 to Study Day 60 ]
    Gain measured in cm

  3. Head Circumference [ Time Frame: Study Day 1 to Study Day 60 ]
    Gain measured in cm


Eligibility Criteria
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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
  • Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
  • 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
  • Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

  • An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development.
  • Participant is receiving oral or inhaled steroids.
  • Participant participates in another study that has not been approved as a concomitant study.
  • Participant has an allergy or intolerance to any ingredient in the study product.
  • Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.
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): NCT03884309


Locations
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United States, Georgia
Paramount Research Solutions
College Park, Georgia, United States, 30349
United States, Kentucky
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, United States, 40356
United States, Nebraska
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68522
United States, Tennessee
Memphis & Shelby County Pediatric Group
Memphis, Tennessee, United States, 38116
United States, Texas
Ventavia Research Group, LLC
Houston, Texas, United States, 77008
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Barbara Marriage, PhD, RD Abbott Nutrition
More Information
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03884309    
Other Study ID Numbers: AL32
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No