An Innovative Probiotic Product With Antiallergic Properties
Primary Purpose
Atopic Dermatitis, Food Allergy, Effects of Probiotics
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotic preparation
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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
Sites / Locations
- The Children's Memorial Health Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Maltodextrin
Arm Description
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 - a substance in which probiotic strains have been suspended.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Changes in the level of total IgE
Total IgE level was measured using the ImmunoCap system according manufacturer's instruction.
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.
Full Information
NCT ID
NCT04738565
First Posted
February 1, 2021
Last Updated
February 1, 2021
Sponsor
Children's Memorial Health Institute, Poland
1. Study Identification
Unique Protocol Identification Number
NCT04738565
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Memorial Health Institute, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Food Allergy, Effects of Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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).
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin - a substance in which probiotic strains have been suspended.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic preparation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin comparable in color, texture and taste to the probiotic mixture administered once a day for 3 months.
Primary Outcome Measure Information:
Title
Changes in severity of atopic dermatitis symptoms assessed with the use the SCORAD index
Description
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.
Time Frame
From baseline at 3 months of intervention and 9 months of follow up
Title
Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms
Description
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.
Time Frame
From baseline at 3 months of intervention and 9 months of follow up
Secondary Outcome Measure Information:
Title
Changes in the level of total IgE
Description
Total IgE level was measured using the ImmunoCap system according manufacturer's instruction.
Time Frame
From baseline at 3 months of intervention and 9 months of follow up
Title
Changes in the level of selected cytokines
Description
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.
Time Frame
From baseline at 3 months of intervention and 9 months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Children's Memorial Health Institute
City
Warsaw
ZIP/Postal Code
04-730
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33916192
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.
Results Reference
derived
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An Innovative Probiotic Product With Antiallergic Properties
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