An Innovative Probiotic Product With Antiallergic Properties

Not Applicable

Completed

• Conditions: Food Allergy; Atopic Dermatitis; Effects of Probiotics
• Interventions: Dietary Supplement: Probiotic preparation; Dietary Supplement: Maltodextrin

• Registration Number: NCT04738565
• Lead Sponsor: Children's Memorial Health Institute, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2014-12-31
• Study Completion: 2015-12-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic preparation	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).
Maltodextrin	Maltodextrin	Maltodextrin - a substance in which probiotic strains have been suspended.

Primary Outcome Measures

Name	Time	Method
Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms	From baseline at 3 months of intervention and 9 months of follow up	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.
Changes in severity of atopic dermatitis symptoms assessed with the use the SCORAD index	From baseline at 3 months of intervention and 9 months of follow up	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the level of selected cytokines	From baseline at 3 months of intervention and 9 months of follow up	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.
Changes in the level of total IgE	From baseline at 3 months of intervention and 9 months of follow up	Total IgE level was measured using the ImmunoCap system according manufacturer's instruction.

Trial Locations

Locations (1)

The Children's Memorial Health Institute; 🇵🇱 Warsaw, Poland