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NOT YET RECRUITING
NCT05443490
NA

Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children

Sponsor: Bionou Research, S.L.

View on ClinicalTrials.gov

Summary

A prospective case-control multicentric pilot study of 12 weeks duration to evaluate the effect of a probiotic mixture in the treatment of atopic dermatitis in children from 0 to 3 years old, by measuring the severity of the condition using the SCORAD index, as well as the Clinical Global Impression rating scale, the potential decrease in the use of corticosteroids and antihistamines, and the safety of the treatment under study by the number of adverse events related to the product under study.

Official title: Randomized, Double Blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children From 0 to 3 Years Old

Key Details

Gender

All

Age Range

6 Months - 3 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-10

Completion Date

2026-11

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic mixture with three bacterial strains with maltodextrin as a carrier.

Sachets containing a probiotic mixture at concentrations equal to or greater than 1x10\^9 colony forming unit (CFU) per dose, with maltodextrin as excipient.

OTHER

Placebo comparator with maltodextrin as a carrier.

Sachets containing maltodextrin

Locations (3)

Hospital del niño Dr. Ovidio Aliaga Uria y Hospital Arco Iris

La Paz, La Paz Department, Bolivia

Centro de Especialidades Dermatológicas Ac S.A (Dermaláser)

San José, Provincia de San José, Costa Rica

Hospital Universitario del Vinalopó

Elche, Alicante, Spain