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CompletedNCT03628183Updated Dec 19, 2018

Tolerance of Infants Fed a Hydrolysate Formula

An interventional study of Hydrolysate Infant Formula 1 and Hydrolysate Infant Formula 2 in Gastrointestinal Tolerance, sponsored by Abbott Nutrition. Completed at 5 sites in United States. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
Up to 14 Days
Sex
All
01

Study summary

This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

02

Conditions studied

  • Gastrointestinal Tolerance
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
Up to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject is judged to be in good health
  • Singleton from a full-term birth
  • Birth weight was > or = to 2490 g
  • Between 0 and 14 days of age at enrollment
  • Parent(s) confirm their intention to feed their infant the assigned study product 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
  • Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion criteria

Exclusion Criteria:

  • An adverse maternal, fetal or subject medical history that is thought by the investigator to have 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 an allergy or intolerance to any ingredient in the study product
  • Subject has been treated with antibiotics within 2 weeks prior to enrollment
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    Hydrolysate Infant Formula 1

    Ready to feed infant formula in can

    Other: Hydrolysate Infant Formula 1

  • Experimental
    Hydrolysate Infant Formula 2

    Ready to feed infant formula in bottle

    Other: Hydrolysate Infant Formula 2

Interventions

  • OtherHydrolysate Infant Formula 1

    Feed ad lib

  • OtherHydrolysate Infant Formula 2

    Feed ad lib

06

What researchers measure

Primary outcomes

  1. Stool Characteristics

    Parent completed diary

    Time frame: Study Day 1 - Study Day 21

Secondary outcomes

  1. Formula Intake

    Parent completed diary

    Time frame: Study Day 1 - Study Day 21

  2. Weight

    Scale

    Time frame: Study Day 1 - Study Day 21

  3. Length

    Length board

    Time frame: Study Day 1 - Study Day 21

07

Study locations

5 sites
  • Watching Over Mothers and Babies
    Tucson, Arizona 85712, United States
  • Springs Medical Research
    Owensboro, Kentucky 42303, United States
  • The Cleveland Pediatric Research Center, LLC
    Cleveland, Ohio 44130, United States
  • Institute of Clinical Research, LLC
    Mentor, Ohio 44060, United States
  • Midsouth Center for Clinical Research
    Memphis, Tennessee 38116, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03628183
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Aug 14, 2018
Start date
Aug 28, 2018
Primary completion
Nov 23, 2018
Completion
Nov 23, 2018
Last update
Dec 19, 2018

Study contacts

Courtney Allgeier, MS, RD, LD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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