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An Innovative Probiotic Product With Antiallergic Properties

NCT04738565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-02-04

No results posted yet for this study

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

Interventions

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.

DIETARY_SUPPLEMENT

Maltodextrin

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

Sponsors & Collaborators

  • Children's Memorial Health Institute, Poland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738565 on ClinicalTrials.gov