Stopped: Combination of factors, including operational, logistical and recruitment challenges impacting the timely execution of the study. The termination was not due to any safety concerns related to the investigational product
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change from baseline in the SCORAD index at 4,8 and 12 weeks
Timeframe: 12 week