Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-04-30

Brief Summary

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Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Galactooligosaccharides

addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula

Group Type EXPERIMENTAL

galactooligosaccharide

Intervention Type OTHER

addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides

Only HA formula

only standard HA starter formula

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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galactooligosaccharide

addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides

Intervention Type OTHER

Other Intervention Names

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GOS prebiotics

Eligibility Criteria

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Inclusion Criteria

* nonbreastfed eutrophic infants of corresponding gestational age
* presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)