Pharyngitis Clinical Trial
Official title:
Effects of Probiotic Addition to Corticosteroid Treatment for PFAPA
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.
Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) was first
described in 1987 in a study of 12 pediatric patients. PFAPA is predominately considered a
pediatric illness with onset typically occurring under the age of 5. This syndrome is
characterized by periodic febrile episodes (39°C - 42°C) lasting an average of 4 days with
recurrence approximately every 21-30 days. Patients classically exhibit at least one of three
major associated symptoms; aphthous stomatitis, pharyngitis, or cervical adenitis. Between
periods of fever, patients are asymptomatic and do not experience long-term deleterious
effects on growth or development. Currently, the etiology of this syndrome is unknown but
does not appear to be heritable or target specific populations.
Due to a lack of applicable diagnostic tests, the identification of PFAPA is predominantly
dependent on patient history and physical examination. This methodology relies heavily upon
clinical presentation of the patient's illness to rule out other causes of periodic fever. As
a result of the unknown cause of PFAPA, there are several proposed treatment approaches
available. Corticosteroids are the current standard of care; typically a single dose of
prednisolone (1 mg/kg), given upon first signs of fever with a subsequent dose during the
febrile period if necessary. Several studies have shown that administration of prednisolone
was sufficient to abort the febrile episode. However, this treatment method typically results
in a decrease in the healthy interval between fever reoccurrence. The reduction in fever
allows for children to attend school and participate in other activates, but the increased
frequency provides additional complications for children and parents.
Oral cimetidine, a histamine H-2 receptor agonist that results in reduced production of
stomach acid, has also been used as possible treatment. This treatment has shown to inhibit
febrile episodes, it was only effective in <30% of patients.
If medication therapy fails to resolve recurrent febrile episodes, the option of
tonsillectomy presents a possible alternative. PFAPA syndrome was shown to resolve in the
majority of patients, however this not preferred as a first line treatment due to the risks
associated with surgery and general anesthesia.
Recently published literature suggests a potential new treatment for PFAPA targeting
chemokines and proinflammatory cytokines. A possible method for the inhibition of cyclic
inflammatory responses in PFAPA would be the exposure of patients to a safe level of
continuous low-grade inflammation, resulting from an immune response. In previous studies
investigating allergy and eczema relief in pediatric populations, it was shown that
administration of probiotics induced elevated levels of inflammatory markers. These low level
inflammatory responses resulted in no adverse effects and provided an immunologic activation
benefit. Use of probiotics provides a previously unstudied approach to the treatment of
PFAPA. Dr. Nicholas Bennett has also observed anecdotal evidence that patients who
self-administered probiotics experienced relief of their PFAPA symptoms.
This is a randomized, prospective, double-blind, placebo-controlled study with the
randomization being done by the research pharmacist using an equal randomization process, no
stratification of patients. Dr. Bennett and other patient recruiters will remain blinded to
the participant group assignment. The standard of care consists of corticosteroid dosing of 1
mg/kg of body weight given once at the onset of the febrile period, repeated once within 24
hours if necessary, but no more than two doses per cycle. The second dose of corticosteroid
is only to be given within one day following the initial dosage if the fever persists. The
investigational product will be administered daily for the duration of the study. For the
investigational product patients will be instructed to take daily one sachet of the study
product mixed into a 60 ml of water that is not hot. On days 90±7, 180±7 and 270±7 patients
will come to the study site for re-supply of the probiotic and for evaluation of compliance.
Throughout the 1-year followup period, parents will be asked to keep a journal to track
corticosteroid usage, probiotic usage, additional medication usage, fever intensity, and
associated symptoms. Standardized thermometers will be provided to ensure consistency. These
journals will be collected and patient progress will be monitored at the standard care visits
every three months. In addition, follow-up phone calls will be made monthly to assess
progress and to address any concerns.
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