Tolerance of Infants Fed a Hydrolysate Formula

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Abbott

Status

Completed

Conditions

Gastrointestinal Tolerance

Treatments

Other: Hydrolysate Infant Formula 1
Other: Hydrolysate Infant Formula 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT03628183
AL30

Details and patient eligibility

About

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

Enrollment

51 patients

Sex

All

Ages

Under 14 days old

Volunteers

Accepts Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 2 patient groups

Hydrolysate Infant Formula 1
Active Comparator group
Description:
Ready to feed infant formula in can
Treatment:
Other: Hydrolysate Infant Formula 1
Hydrolysate Infant Formula 2
Experimental group
Description:
Ready to feed infant formula in bottle
Treatment:
Other: Hydrolysate Infant Formula 2

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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