NCT04738565

An Innovative Probiotic Product With Antiallergic Properties

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Children's Memorial Health Institute, Poland · Academic / Other
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-31
• Completion: 2015-12-31
• First posted: 2021-02-04
• Last updated: 2021-02-04

Locations

1 site across 1 country: Poland