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Gastrointestinal Tolerance of Infant Formula

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ClinicalTrials.gov Identifier: NCT02322138
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tolerance Other: Experimental 1 Infant Formula Other: Experimental 2 Infant Formula Other: Reference Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Gastrointestinal Tolerance of Formula Supplemented With Prebiotics
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental 1 Infant Formula
Milk-based infant formula without prebiotics
Other: Experimental 1 Infant Formula
Ready to feed infant formula to be fed ad-libitum

Experimental: Experimental 2 Infant Formula
Milk-based infant formula with prebiotics
Other: Experimental 2 Infant Formula
Ready to feed infant formula to be fed ad-libitum

Human Milk-Fed Reference Group
Breast fed infants
Other: Reference Group
Breast fed ad libitum




Primary Outcome Measures :
  1. Stool Consistency Questionnaire [ Time Frame: Baseline to 35 Days of Age ]
    Questionnaire


Secondary Outcome Measures :
  1. Stools per Day Questionnaire [ Time Frame: Baseline to 35 Days of Age ]
    Questionnaire

  2. Feeding Spit Up Questionnaire [ Time Frame: Baseline to 35 Days of Age ]
    Questionnaire

  3. Weight [ Time Frame: Baseline to 35 Days of Age ]
    Measured

  4. Length [ Time Frame: Baseline to 35 Days of Age ]
    Measured

  5. Head Circumference [ Time Frame: Baseline to 35 Days of Age ]
    Measured



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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:

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
  • Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
  • Infant is between 0 and 8 days of age at enrollment.
  • Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
  • 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:

  • Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
  • Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
  • Mother intends to use a combination of breast and formula feeding.
  • Participation in another study that has not been approved as a concomitant study by AN.

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): NCT02322138


Locations
United States, Arizona
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, United States, 85712
United States, Colorado
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, United States, 80920
United States, Connecticut
Norwich Pediatric Group, PC
Norwich, Connecticut, United States, 06360
United States, Florida
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States, 33710
United States, Kentucky
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, United States, 40356
United States, Nebraska
Women's Clinic of Lincoln, PC.
Lincoln, Nebraska, United States, 68510
United States, North Carolina
White Oak Family Physicians DBA Asheboro Research Associates
Asheboro, North Carolina, United States, 27203
United States, Ohio
Institute of Clinical Research
Mayfield Heights,, Ohio, United States, 44124
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Utah
Tanner Memorial Clinic
Layton, Utah, United States, 84041
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Janice Kajzer, MS, RD, LD Abbott Nutrition

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02322138     History of Changes
Other Study ID Numbers: AL14
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015