Prebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled Trial

Jan Boženský, Martin Hill, Richard Zelenka, Tomáš Skýba, Jan Boženský, Martin Hill, Richard Zelenka, Tomáš Skýba

Abstract

The objective was to evaluate the effects of a hypoallergenic (HA) formula supplemented with prebiotic galacto-oligosaccharides on the severity of atopic manifestations. A randomised clinical trial was conducted. The control group was infants, fed with hypoallergenic formula and without supplementation. The duration of the study was six months. The primary outcome of the study was a difference in the severity of atopic dermatitis measured using SCORAD (Scoring Atopic Dermatitis) criteria. Secondary outcomes were anthropometry (length, weight, and head circumference), together with the tolerance and incidence of infections. Both groups showed a decrease of average SCORAD values, but no statistically significant difference between the evaluated groups was observed. There were no statistically significant differences in anthropometry, or the tolerance or incidence of infections. Although there is no evidence, that consumption of a hypoallergenic infant formula enriched with prebiotic galacto-oligosaccharides had any effect on SCORAD, it was safe and well tolerated.

Trial registration: www.clinicaltrials.gov NCT 02077088.

Trial registration: ClinicalTrials.gov NCT02077088.

Conflict of interest statement

Competing Interests: RZ is employed by the study sponsor. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flow-chart of infant participation (CONSORT…
Fig 1. Flow-chart of infant participation (CONSORT 2010) Corresponding checklist is provided as S1 CONSORT Checklist.
Fig 2. Comparison of SCORAD score.
Fig 2. Comparison of SCORAD score.
Bars represent 95% CI intervals, closed circles study group, open circles control group. At baseline 120 infants were included, at 3 month follow-up 109 infants were included, at 6 months 103 infants finished the study.

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