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CompletedNCT01155414Updated Nov 1, 2011

Tolerance of Healthy Term Infants Fed Infant Formulas #4

A Phase 3 interventional study of Hydrolysate based infant formula and Investigational Infant Formula A in Healthy Term Infants, sponsored by Abbott Nutrition. Completed at 10 sites in United States. Open to participants aged 1 Day to 8 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-01.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
1 Day to 8 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Term Infants
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 8 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • An adverse maternal, fetal or infant medical history and treatment with antibiotics
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Investigational infant formula A

    Investigational Protein Hydrolysate formula

    Other: Investigational Infant Formula A

  • Active comparator
    Hydrolysate based Infant Formula

    Other: Hydrolysate based infant formula

  • Experimental
    Investigational Infant Formula B

    Investigational Protein Hydrolysate Formula

    Other: Investigational Infant Formula B

Interventions

  • OtherHydrolysate based infant formula

    Infant formula ad lib

  • OtherInvestigational Infant Formula A

    Investigational infant formula ad lib

  • OtherInvestigational Infant Formula B

    Investigational infant formula ad lib

06

What researchers measure

Primary outcomes

  1. GI tolerance via stool consistency

    Time frame: 28 days

07

Study locations

10 sites
  • Alabama Clinical Therapeutics, LLC
    Birmingham, Alabama 35235, United States
  • Alabama Clinical Therapeutics, LLC
    Dothan, Alabama 36305, United States
  • SCORE Physician Alliance
    St. Petersburg, Florida 33710, United States
  • University of Iowa
    Coralville, Iowa 52241, United States
  • Medical Associates Clinic, PC
    Dubuque, Iowa 52001, United States
  • MetroHealth Medical Center
    Cleveland, Ohio 44109, United States
  • Ohio Pediatric Research Association
    Huber Heights, Ohio 45424, United States
  • Institute of Clinical Research
    Mayfield Heights, Ohio 44124, United States
  • Pediatric Clinical Research Office
    Hershey, Pennsylvania 17033, United States
  • The Jackson Clinic, PA
    Jackson, Tennessee 38305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01155414
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Jul 1, 2010
Start date
Mar 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Nov 1, 2011

Study contacts

Marlene Borschel, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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