An Innovative Probiotic Product With Antiallergic Properties

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.

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis; Food Allergy; Effects of Probiotics
• Intervention / Treatment: Dietary supplement: Probiotic preparation; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-730
    • The Children's Memorial Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic; 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; 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.
PLACEBO_COMPARATOR: Maltodextrin; Maltodextrin - a substance in which probiotic strains have been suspended.	Dietary supplement: Maltodextrin; Maltodextrin comparable in color, texture and taste to the probiotic mixture administered once a day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From baseline at 3 months of intervention and 9 months of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the level of total IgE	Total IgE level was measured using the ImmunoCap system according manufacturer's instruction.	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.	From baseline at 3 months of intervention and 9 months of follow up

Collaborators and Investigators

• Sponsor: Children's Memorial Health Institute, Poland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2012
• Primary Completion (ACTUAL): December 31, 2014
• Study Completion (ACTUAL): December 31, 2015

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Food Hypersensitivity
• Other Study ID Numbers: N R12-0101-10/2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No