drugset / Trial / NCT02535962

Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA)

NCT02535962

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of study is to see if adding probiotics to corticosteroid treatment for children with PFAPA could improve the health and daily of patients through reduction in febrile period frequency and length, along with concomitant reduction of associated symptoms. Current standard of care incorporates the administration of corticosteroids; however, while limiting the symptoms associated with PFAPA, corticosteroid use has been shown to increase the frequency at which these symptoms occur. Investigators hypothesize that administration of probiotics along with corticosteroids will work to decrease the frequency at which the febrile episodes occur. Additionally, probiotics may decrease the maximal fever experienced during these episodes, amount of corticosteroid needed to control the symptoms, average length of the episodes, and the number of patients who ultimately undergo tonsillectomy due to unsuccessful treatment with medication.

Timeline

Start
2016-10
Primary completion
2017-09
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus Unknown 5e+09 unknown Oral
Subject Lactobacillus acidophilus Other / unclassified 5e+09 unknown Oral