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
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedMarch 4, 2014
February 1, 2014
3.4 years
January 2, 2014
February 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
objective evaluation of atopic symptoms
at 6 months of age
Secondary Outcomes (1)
anthropometric parameters (height, weight)
at 6 months of age
Other Outcomes (1)
incidence of febrile episodes
at 6 months
Study Arms (2)
Galactooligosaccharides
EXPERIMENTALaddition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula
Only HA formula
NO INTERVENTIONonly standard HA starter formula
Interventions
addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- children with serious disease,
- breastfed children
- children fed another formula then the ones used
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Humana Co.Ltd.lead
- Vitkovice Hospitalcollaborator
Study Sites (1)
Vitkovice Hospital
Ostrava-Vitkovice, 70384, Czechia
Related Publications (1)
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.
PMID: 26571488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Bozensky, MD
Vitkovice Hospital, Ostrava, Czech Republic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2014
First Posted
March 4, 2014
Study Start
June 1, 2009
Primary Completion
November 1, 2012
Study Completion
April 1, 2013
Last Updated
March 4, 2014
Record last verified: 2014-02