Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

N/ACompletedNCT02077088

Humana Co.Ltd.120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Atopic Dermatitis

Interventions

galactooligosaccharideOTHER

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

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 8 Weeks

Medical Language ↔ Plain English

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) Exclusion Criteria: * children with serious disease, * breastfed children * children fed another formula then the ones used

Locations (1)

Vitkovice Hospital

Ostrava-Vitkovice, Czechia

Outcomes

Primary Outcomes

SCORAD (SCORing Atopic Dermatitis score) assessment of atopy

objective evaluation of atopic symptoms

Time frame: at 6 months of age

Secondary Outcomes

anthropometric parameters (height, weight)

Time frame: at 6 months of age

Data from ClinicalTrials.gov

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