The Use of Streptococcus salivarius K12 in treatment of Periodic fever with aphthous stomatitis, pharyngitis, and adenitis (PFAPA) Syndrome

Determination of the effectiveness of the probiotic Streptococcus salivarius K12 in the treatment of patients with Periodic fever , aphthous stomatitis, pharyngitis, and adenitis (PFAPA) Syndrome

Clinical trial with control group, with parallel groups, three-arm blind, randomized, phase 2 on 30 patients. This will be done using the random block method using the site sealedenvelop.com.

in this study, children with a diagnosis of PFAPA referred to the rheumatology and allergy clinic of Akbar Children's Hospital in Mashhad are divided into two groups.one group receive lactogam and other group get plasebo

Inclusion criteria: All patients under 18 who are diagnosed with PFAPA based on the Marshall Crater by a pediatric rheumatologist. Non-entry conditions: 1-Parents' dissatisfaction to participate in the project, 2-All patients with overlap syndrome

In this randomized trial study, patients with a diagnosis of PFAPA based on Marshall Crater will be divided into two groups. . In one group, in addition to the previously used therapies, lactogam therapy (manufactured by Zist Takhmiir Company), which contains the probiotic Streptococcus salivarius K12( >10⁹CFU), should be used by the patient as a suction for 4 months and at night before going to bed. The other group (control) under previous standard treatments will include acetaminophen and the NSAID prednisolone. A placebo will also be used in this group (control) where the placebo will be similar in shape and color to the intervention group. The method of prescribing it will be the same.

Evaluation of the number of disease attacks in case and control groups, Investigating the distance between the incidence of attacks in the case and control groups, Determining the change in the number of symptoms in attacks in the case group

Block Randomization will be performed using the quadratic block method. A random sequence based on quadratic blocks will be generated by the design methodologist using the sealedenvelope.com website. The sequence produced in sealed envelopes will be opaque and sealed and then numbered sequentially. The person allocating the samples will open the envelopes in order after fulfilling the entry conditions of the participants.

blinding (study subjects, evaluators, analysts) Due to the use of placebo in the control group, participants will be blinded to the study group. Outcome assessment will be performed by a person separate from the patient's therapist and this person will not be aware of the assigned groups. The data are specified in groups a and b at the time of analysis and the data analyst will be unaware of the intervention and control group.