Behavior of Infants Fed Formula Supplemented With Prebiotics

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Abbott

Status

Completed

Conditions

Gastrointestinal Tolerance

Treatments

Other: Infant formula supplemented with prebiotics

Study type

Interventional

Funder types

Industry

Identifiers

NCT02757924
AL20

Details and patient eligibility

About

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Enrollment

59 patients

Sex

All

Ages

7 to 42 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subject is judged to be in good health.
  • Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
  • Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
  • Infant was identified by parents as very fussy or extremely fussy.
  • Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the 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.

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 (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
  • Subject participates in another study that has not been approved as a concomitant study.
  • Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
  • Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
  • Mother intends to use a combination of breast and formula feeding.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

Infant formula supplemented with prebiotics
Experimental group
Description:
infant formula powder, feed ad libitum
Treatment:
Other: Infant formula supplemented with prebiotics

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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