An Innovative Probiotic Product With Antiallergic Properties

NCT04738565 | Completed

• 1 other identifier: N R12-0101-10/2011
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Food Allergy; Effects of Probiotics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in the level of total IgE

  From baseline at 3 months of intervention and 9 months of follow up

• Changes in the level of selected cytokines

  From baseline at 3 months of intervention and 9 months of follow up

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

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.

Probiotic

Maltodextrin DIETARY_SUPPLEMENT

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

Maltodextrin

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead

Study Sites (1)

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Location

Related Publications (1)

• 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.

  PMID: 33916192 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Food Hypersensitivity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine, MD, PhD

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: June 1, 2012
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2015
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

PL (1)