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

NCT05443490 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Biopolis S.L.

    collaborator INDUSTRY

  • Bionou Research, S.L.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Bolivia
  • Costa Rica
  • Spain

Study Locations

More Related Trials

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 NCT05443490 on ClinicalTrials.gov