Atopic Dermatitis
Conditions
Keywords
interventional, doubleblind, randomised, pediatric, prebiotic, atopic, dermatitis, infant
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
Interventions
addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
Sponsors
Vitkovice Hospital
Humana Co.Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD (SCORing Atopic Dermatitis score) assessment of atopy | at 6 months of age | objective evaluation of atopic symptoms |
Secondary
| Measure | Time frame |
|---|---|
| anthropometric parameters (height, weight) | at 6 months of age |
Other
| Measure | Time frame |
|---|---|
| incidence of febrile episodes | at 6 months |
Countries
Czechia
Outcome results
None listed