Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Humana

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: galactooligosaccharide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02077088

1.090

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Galactooligosaccharides

Experimental group

Description:

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

Treatment:

Other: galactooligosaccharide

Only HA formula

No Intervention group

Description:

only standard HA starter formula