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Effect of Formula on Infant Behavior

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: NCT02746016
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tolerance Other: Infant Formula supplemented with Oligosaccharides Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Infant Formula supplemented with Oligosaccharides
Ready to feed infant formula ; Feed ad libitum.
Other: Infant Formula supplemented with Oligosaccharides
sole source nutrition




Primary Outcome Measures :
  1. Fussiness [ Time Frame: Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1) ]
    Parent Questionnaires


Secondary Outcome Measures :
  1. Fussiness [ Time Frame: Baseline to SDAY 29 ]
    Parent Questionnaires

  2. Hours of daily crying [ Time Frame: Baseline to SDAY 29 ]
    Parent Questionnaires

  3. Gastrointestinal Tolerance [ Time Frame: Baseline to SDAY 29 ]
    Parent Questionnaires

  4. Stool Pattern [ Time Frame: Baseline to SDAY 29 ]
    Parent Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 42 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good health as determined from subject's medical history by parent report
  • Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
  • Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
  • Subject is between 7 and 42 days of age
  • Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
  • Infant is exclusively formula-fed at time of study entry
  • 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
  • Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion Criteria:

  • An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
  • Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
  • Subject participates in another study that has not been approved as a concomitant study
  • Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
  • Subject has been treated with oral antibiotics within 7 days prior to study enrollment
  • Mother intends to use a combination of breast and formula feeding

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): NCT02746016


Locations
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United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
United States, Arizona
Watching Over Mothers and Babies
Tucson, Arizona, United States, 85712
United States, Connecticut
Norwich Pediatric Group, PC
Norwich, Connecticut, United States, 06360
United States, Florida
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States, 32825
Score Physician Alliance, LLC
Saint Petersburg, Florida, United States, 33710
United States, Nebraska
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States, 68510
United States, Ohio
Institute of Clinical Research, LLC
Cleveland, Ohio, United States, 44124
Aventiv Research
Grove City, Ohio, United States, 43123
United States, South Carolina
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
United States, Texas
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Southwest Children's Research Associates, P.A.
San Antonio, Texas, United States, 78229
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Marlene Borschel, PhD, RD Abbott Nutrition
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02746016    
Other Study ID Numbers: AL19
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided