Formula Tolerance of Term Infants

Tolerance of Term Infants Fed Formula With Oligosaccharides

To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants

Study Overview

• Status: Completed
• Conditions: Gastro-Intestinal Tolerance
• Intervention / Treatment: Other: Study Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • MedPharmics, LLC
  • Florida
    • Miami, Florida, United States, 33126
      • Dade Research Center, LLC
  • Georgia
    • Macon, Georgia, United States, 31210
      • Meridian Clincial Research- Macan
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • MedPharmics
  • Montana
    • Kalispell, Montana, United States, 59901
      • Boeson Research Kalispell
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies
  • Tennessee
    • Memphis, Tennessee, United States, 38115
      • AVIATI Healthcare & Clinical Research
  • Texas
    • Edinburg, Texas, United States, 78539
      • Invesclinic US LLC
    • League City, Texas, United States, 77573
      • Maximos Ob/Gyn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant is judged to be in good health as determined from participant's medical history by parent report
• Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
• Participant's birth weight was >= 2490 g (~5 lbs. 8 oz.)
• Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
• Participant is exclusively formula-fed at time of study entry and 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, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
• Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local 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 tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
• Participant is taking and plans to continue taking 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.
• Participant participates in another study that has not been approved as a concomitant study
• Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
• Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
• Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
• Participant has been treated with antibiotics within 7 days prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Infant Formula; Feed ad libitum during study period	Other: Study Infant Formula; RTF milk-based infant formula with oligosaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fussiness	Absolute and % change in fussiness severity reported from Daily Tolerance Diary	Baseline to Study Day (SDAY) 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerance	Parent Completed Diary	Baseline to SDAY 28
Stool	Parent Completed Diary	Baseline to SDAY 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula Intake	Parent Completed Diary	SDAY 1 to SDAY 28
Weight	Weight gains, percentiles, and z-scores	SDAY 1 to SDAY 28
Length	Length gains, percentiles, and z-scores	SDAY 1 to SDAY 28
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent	SDAY 1 and SDAY 28
Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative	SDAY 1 and SDAY 28
Parental perspectives	Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive	SDAY 1 and SDAY 28
Health Resource Utilization	Number of Visits	SDAY 7 and SDAY 28
Adverse Events	Standard adverse event reporting	SDAY 1 to SDAY 28

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Elizabeth Reverri, PhD, MS, RD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AL41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No