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NCT02077088 Clinical Trial

Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02077088
Other study ID # 1.090
Secondary ID
Status Completed
Phase N/A
First received January 2, 2014
Last updated February 28, 2014
Start date June 2009
Est. completion date April 2013

Study information
Verified date February 2014
Source Humana Co.Ltd.
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Weeks to 8 Weeks
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• galactooligosaccharide
addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides

Locations
Country Name City State
Czech Republic Vitkovice Hospital Ostrava-Vitkovice

Sponsors (2)
Lead Sponsor Collaborator
Humana Co.Ltd. Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Other incidence of febrile episodes at 6 months Yes
Primary SCORAD (SCORing Atopic Dermatitis score) assessment of atopy objective evaluation of atopic symptoms at 6 months of age No
Secondary anthropometric parameters (height, weight) at 6 months of age Yes
See also
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