Behavior of Infants Fed Formula Supplemented With Prebiotics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-02

Brief Summary

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

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Detailed Description

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Conditions

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Gastrointestinal Tolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Infant formula supplemented with prebiotics

infant formula powder, feed ad libitum

Group Type EXPERIMENTAL

Infant formula supplemented with prebiotics

Intervention Type OTHER

Sole source nutrition

Interventions

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Infant formula supplemented with prebiotics

Sole source nutrition

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

7 Days

Maximum Eligible Age

42 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes