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

NCT02535962 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-01-24

No results posted yet for this study

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.

Conditions

  • Periodic Fever
  • Aphthous Stomatitis
  • Pharyngitis
  • Cervical Adenitis

Interventions

BIOLOGICAL

Lactobacillus acidophilus and Bifidobacterium lactis

study product will be freeze dried and put into foil sachets

OTHER

Placebo

Placebo will look and taste like the investigational product. This also will be provided in a foil sachets

Sponsors & Collaborators

  • DuPont Nutrition and Health

    collaborator INDUSTRY

  • Connecticut Children's Medical Center

    lead OTHER

Principal Investigators

  • Nicholas Bennett, MBBChir PhD · Connecticut Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

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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 NCT02535962 on ClinicalTrials.gov