An interventional study of Probiotic preparation and Maltodextrin in Atopic Dermatitis, Food Allergy and Effects of Probiotics, sponsored by Children's Memorial Health Institute, Poland. Completed at 1 site in Poland. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Children's Memorial Health Institute, Poland · Not applicable, Interventional, and Treatment
Allergic diseases are currently one of the most important problem in medicine. Research confirms that probiotics administered during the formation of the intestinal ecosystem and the maturation of the immune system can positively influence the development of antiallergic mechanisms. The aim of the present randomized, double-blind, placebo controlled study was to evaluate the efficacy of the mixture of probiotic Lactobacillus rhamnosus ŁOCK 0900, Lactobacillus rhamnosus ŁOCK 0908, and Lactobacillus casei ŁOCK 0919 in children up to the age 2 with atopic dermatitis and food allergy to cow's milk proteins. Children received the mixture of Lactobacillus strains for 3 months every day in the daily dose of a billion bacteria or a placebo (maltodextrin). Primary outcomes included the effects of probiotic treatment on the severity of symptoms assessed with SCORing atopic dermatitis (SCORAD) index. Secondary endpoints included assessment of total IgE and selected cytokine levels. Cytokines were evaluated in supernatants obtained from peripheral blood cultures of randomly selected 20 patients from each group. The primary and secondary outcomes were assessed at 3 time points: at baseline, after the finishing the administration of probiotic/placebo, and after 9 months of follow up.
Exclusion Criteria:
The mixture of 3 probiotic strains in the following proportions: 50% Lactobacillus casei ŁOCK 0919, 25% Lactobacillus rhamnosus ŁOCK 0908, 25% Lactobacillus rhamnosus ŁOCK 0900 (Latopic® preparation, Biomed S.A., Cracow, Poland).
Dietary Supplement: Probiotic preparation
Maltodextrin - a substance in which probiotic strains have been suspended.
Dietary Supplement: Maltodextrin
The mixture of Lactobacillus rhamnosus ŁOCK 0900, Lactobacillus rhamnosus ŁOCK 0908 and Lactobacillus casei ŁOCK 0919 administered once a day at a dose of one billion for 3 months.
Maltodextrin comparable in color, texture and taste to the probiotic mixture administered once a day for 3 months.
Changes in severity of atopic dermatitis symptoms assessed with the use the SCORAD index
The SCORAD index consists of the interpretation of the extent of the disorder (A: according to the rule of nines; 20% of the score), the intensity composed of six items (B: erythema, oedema ⁄papules, effect of scratching, oozing ⁄crust formation, lichenification and dryness; 60% of the score; each item has four grades: 0,1, 2, 3) and subjective symptoms (C: itch, sleeplessness; 20% of the score). Both subjective items are graded on a 10-cm visual analogue scale. The SCORAD index formula is: A ⁄5 + 7B⁄2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximum SCORAD score is 103.
Time frame: From baseline at 3 months of intervention and 9 months of follow up
Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms
Atopic dermatitis symptoms were assessed with the use of the SCORAD index. It was assumed that a drop \>30% in the SCORAD index compared with baseline was associated with a clinically meaningful improvement. A drop\<30% was associated with worsening.
Time frame: From baseline at 3 months of intervention and 9 months of follow up
Changes in the level of total IgE
Total IgE level was measured using the ImmunoCap system according manufacturer's instruction.
Time frame: From baseline at 3 months of intervention and 9 months of follow up
Changes in the level of selected cytokines
The level of proinflammatory Th1 cytokines (e.g. interferon-gamma, interleukin-12), regulatory cytokines (e.g. intreleukin-10) or proallergic Th2 cytokines (e.g. interleukin-5) were measured in the supernatants obtained from the peripheral blood cultures with the use of ELISA techniques.
Time frame: From baseline at 3 months of intervention and 9 months of follow up
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Children's Memorial Health Institute, Poland