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Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children
Sponsor: Bionou Research, S.L.
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
Conditions
Interventions
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.
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