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NCT Number: NCT04738565

An Innovative Probiotic Product With Antiallergic Properties

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Effects of Probiotics Food Allergy Food Hypersensitivity Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic preparation

Dietary Supplement

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

Dietary Supplement

Maltodextrin comparable in color, texture and taste to the probiotic mixture administered once a day for 3 months.

Primary outcomes

  1. Changes in severity of atopic dermatitis symptoms assessed with the use the SCORAD index

    Time frame: 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.

  2. Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms

    Time frame: 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.

Secondary outcomes

  1. Changes in the level of total IgE

    Time frame: 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.

  2. Changes in the level of selected cytokines

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Memorial Health Institute, Poland

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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