NCT04738565

An Innovative Probiotic Product With Antiallergic Properties

Completed NA Last updated 4 February 2021

What this trial tests

NA trial testing Probiotic preparation in Atopic Dermatitis in 150 participants. Completed in 31 December 2015.

Timeline

1 June 2012

Primary endpoint
31 December 2014

31 December 2015

Quick facts

Lead sponsor	Children's Memorial Health Institute, Poland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	150
Start date	1 June 2012
Primary completion	31 December 2014
Estimated completion	31 December 2015
Sites	1 location across Poland

Drugs / interventions tested

• Probiotic preparation
• Maltodextrin (MALTODEXTRIN) — full drug profile →

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Food Allergy — all drugs for Food Allergy →
• Effects of Probiotics — all drugs for Effects of Probiotics →

Sponsor

Children's Memorial Health Institute, Poland

Who can join

Adults 1 Month to 24 Months, any sex, with Atopic Dermatitis or Food Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effectiveness of Probiotic <i>Lactobacillus rhamnosus</i> and <i>Lactobacillus casei</i> Strains in Children with Atopic Dermatitis and Cow's Milk Protein Allergy: A Multicenter, Randomized, Double Blind, Placebo Controlled Study.
   Cukrowska B, Ceregra A, Maciorkowska E, Surowska B, et al · · 2021 · cited 60× · PMID 33916192 · DOI 10.3390/nu13041169
2. Recent advances in therapeutic probiotics: insights from human trials.
   Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24