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Completed

NCT Number: NCT02077088

Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

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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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitkovice Hospital

Ostrava-Vitkovice, 70384, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

galactooligosaccharide

Other

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

Other names: GOS, prebiotics

Primary outcomes

  1. SCORAD (SCORing Atopic Dermatitis score) assessment of atopy

    Time frame: at 6 months of age

    objective evaluation of atopic symptoms

Secondary outcomes

  1. anthropometric parameters (height, weight)

    Time frame: at 6 months of age

Other outcomes

  1. incidence of febrile episodes

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

Humana Co.Ltd.

Industry

Collaborators

  • Vitkovice Hospital

Registry information

Official study title

Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 4, 2014
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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