Clinical trial NCT04738565: An Innovative Probiotic Product With Antiallergic Properties
Official title: An Innovative Probiotic Product With Antiallergic Properties. The Effectiveness of a Mixture of Lactobacillus ŁOCK Strains in Children With Atopic Dermatitis - Multicentre, Randomized, Double-blind Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Food Allergy
Effects of Probiotics
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in severity of atopic dermatitis symptoms assessed with the use the SCORAD index
timeFrame: From baseline at 3 months of intervention and 9 months of follow up
measure: Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms
timeFrame: From baseline at 3 months of intervention and 9 months of follow up
Secondary outcomes:
measure: Changes in the level of total IgE
timeFrame: From baseline at 3 months of intervention and 9 months of follow up
measure: Changes in the level of selected cytokines
timeFrame: From baseline at 3 months of intervention and 9 months of follow up
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Children's Memorial Health Institute
Study officials:
References:
citation: Cukrowska B, Ceregra A, Maciorkowska E, Surowska B, Zegadlo-Mylik MA, Konopka E, Trojanowska I, Zakrzewska M, Bierla JB, Zakrzewski M, Kanarek E, Motyl I. The Effectiveness of Probiotic Lactobacillus rhamnosus and Lactobacillus casei Strains in Children with Atopic Dermatitis and Cow's Milk Protein Allergy: A Multicenter, Randomized, Double Blind, Placebo Controlled Study. Nutrients. 2021 Apr 1;13(4):1169. doi: 10.3390/nu13041169.