Pharyngitis Clinical Trial
— PFAPAOfficial title:
Effects of Probiotic Addition to Corticosteroid Treatment for PFAPA
Verified date | January 2018 |
Source | Connecticut Children's Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 12 Years |
Eligibility |
Inclusion Criteria: - diagnosis or confirmation of diagnosis of PFAPA from Dr. Bennett based on clinical or laboratory data - is or will be undergoing treatment for PFAPA at CCMC - agrees to the consent and, if necessary, assent forms - is between 1 and 12 years of age Exclusion Criteria: - is currently taking another probiotic regularly (>=2 times/ week) - is allergic to ingredients in the probiotic or placebo - may react adversely to the probiotic due to any form of immune deficiency or chronic disease including pulmonary, renal, cardiac disorders including underlying structural heart disease, gastrointestinal disease, or diabetes - is not a proficient English speaker - does not agree to the consent and/or assent forms - patients who use antibiotics or have used them within a month of the study start |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center | DuPont Nutrition and Health |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effects of the investigational treatment | Increased healthy intervals between cyclic febrile episodes in patients with PFAPA compared to patients being solely treated with corticosteroids. | Time to event: number of fever-free days will be calculated, as well as the average number of days between fever cycles from baseline to end of study which is 12 months. | |
Primary | Safety of the investigational treatment - reported descriptively as percentages of patients experiencing adverse and serious adverse events. | Safety will be reported descriptively as percentages of patients experiencing adverse and serious adverse events. | Time to event: number of fever-free days will be calculated, as well as the average number of days between fever cycles from baseline to end of study which is 12 months. | |
Secondary | Maximal fever experienced during a PFAPA febrile episode will be recorded as an average of the peak temperature recorded during each episode throughout the year and compared between the study groups | Decreased maximal fever experienced during a PFAPA febrile episode. | Maximal fever experienced during a PFAPA febrile episode will be recorded as an average of the peak temperature recorded during each episode throughout the year | |
Secondary | Number of administrations of corticosteroid necessary for treatment of PFAPA syndrome, recorded as the average number of administrations per fever episode throughout the year | Decreased administrations of corticosteroid necessary for treatment of PFAPA syndrome. | Number of administrations of corticosteroid necessary for treatment of PFAPA syndrome, recorded as the average number of administrations per fever episode throughout the year | |
Secondary | The average duration of the individual cyclic febrile episodes | Decrease duration of the individual cyclic febrile episodes in patients with PFAPA. | average duration of the individual cyclic febrile episodes in patients with PFAPA will be assessed from baseline to the end of study which is 1 year | |
Secondary | The number of patients undergoing tonsillectomy will be compared between the study groups | Fewer patients undergoing tonsillectomy as a treatment for PFAPA syndrome | At any time during the study from baseline to end of study, which is 12 months this will recorded |
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