NCT02077088|Completed
Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants
Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants
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Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants
Sponsor study identifier
interventional
120
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
April 2013
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 2012
Actual (reported)April 2013
Actual (reported)January 2, 2014
Actual (reported)March 4, 2014
Actual (reported)SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
objective evaluation of atopic symptoms
at 6 months of age
anthropometric parameters (height, weight)
at 6 months of age
incidence of febrile episodes
at 6 months
addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula
only standard HA starter formula
addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vitkovice Hospital
Ostrava-Vitkovice, 70384, Czechia
Bozensky J, Hill M, Zelenka R, Skyba T. Prebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled Trial. PLoS One. 2015 Nov 16;10(11):e0142897. doi: 10.1371/journal.pone.0142897. eCollection 2015.
Jan Bozensky, MD
Vitkovice Hospital, Ostrava, Czech Republic
120 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2014
First Posted
March 4, 2014
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Contact the study team to confirm eligibility.
Primary Completion
November 2012
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
March 4, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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