Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: galactooligosaccharide

• Registration Number: NCT02077088
• Lead Sponsor: Humana Co.Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-11
• Study Completion: 2013-04
• Study First Submitted: 2014-01-02
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-28
• Last Update Submitted: 2014-02-28
• Study First Posted: 2014-03-04
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galactooligosaccharides	galactooligosaccharide	addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula

Primary Outcome Measures

Name	Time	Method
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy	at 6 months of age	objective evaluation of atopic symptoms

Secondary Outcome Measures

Name	Time	Method
anthropometric parameters (height, weight)	at 6 months of age

Trial Locations

Locations (1)

Vitkovice Hospital; 🇨🇿 Ostrava-Vitkovice, Czech Republic