A highly hydrolyzed formula based on whey protein with the prebiotics galactooligosaccharides and fructooligosaccharides effectively abolishes the symptoms of atopic dermatitis: Results of a multicenter open-label trial in Russia

Most cases of atopic dermatitis are caused by allergy to cow’s milk proteins in babies in their first year of life. Dietotherapy with highly hydrolyzed formulas is the basis for timely and adequate medical care to these children. The objective of the open-label multicenter prospective postregistration trial was to evaluate the efficacy of a formula based on the in-depth hydrolysis of whey proteins with the prebiotics GOS/lcFOS 0,8 g/100 ml for infants within their first year of life who received artificial nutrition and suffered from topical dermatitis presumably associated with allergy to cow’s milk proteins. The trial enrolled 51 babies aged 193,64 (SD 73,95) days with mild and moderate atopic dermatitis (SCORAD<40). Results. During a 4-week dietotherapy cycle, there was abolishment of the skin symptoms of atopic dermatitis (SCORAD 26,66 (SD 9,19) and 6,63 (SD 4,36)) at the beginning and end of the trial and a reduction in the needs for topical glucocorticosteroids, zinc-containing topical agents and antihistamines (p<0,01). The individual visual analogue scale efficiency of the dietotherapy was 8,53 (SD 1,51) and 8,72 (SD 1,20) scores as assessed by the parents and physicians, respectively. During the dietotherapy, the physiological rate of defecations was 1,88 (SD 0,94) times/day, the characteristics of stool significantly improved. The average daily formula intake was 786,13 (SD 169,21) ml. Weight-for-height in all the infants was in the normal range. Conclusion. The test formula is well tolerated and effective in more than 90% of the infants with atopic dermatitis presumably associated with allergy to cow’s milk proteins and ensures a child’s growth and development