An Innovative Probiotic Product With Antiallergic Properties

Children's Memorial Health Institute, Poland

Status: Completed

Conditions: Atopic Dermatitis; Effects of Probiotics; Food Allergy

Treatments: Dietary Supplement: Probiotic preparation; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT04738565

N R12-0101-10/2011

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of atopic dermatitis according to Hanifin and Rajka criteria,
• age under 2 years (24 months)
• the SCORAD index >10
• suspected allergy to cow's milk protein

Exclusion criteria

• acute infections of skin,
• presence of other severe diseases
• treatment with systemic corticosteroids
• treatment with antibiotics for at least 6 weeks prior to study enrollment
• use of probiotics for the last 6 weeks prior to study enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Probiotic preparation

Maltodextrin

Placebo Comparator group

Description:

Maltodextrin - a substance in which probiotic strains have been suspended.

Treatment:

Dietary Supplement: Maltodextrin