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IRCT20210911052436N1 IRCT 2021-11-27 Mashhad University of Medical Sciences Evaluation of the effect of probiotics on periodic fever PFAPA The Use of Streptococcus salivarius K12 in treatment of Periodic fever with aphthous stomatitis, pharyngitis, and adenitis (PFAPA) Syndrome 2021-09-01 anticipated 30 Complete https://irct.ir/trial/58774 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 description: 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. 3 Periodic fever with aphthous stomatitis, pharyngitis, and adenitis. Intervention 1: Intervention group: In addition to the previously used treatments, treatment with lactogam (manufactured by Bio Fermentation 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. Intervention 2: Control group: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Nafiseh Pourbadakhshan
17 shahrivar 5
Mashhad Iran (Islamic Republic of) 9166655688 +98 51 3859 6431 pourbadakhshann@mums.ac.ir Mashhad University of Medical Sciences scientific Nafiseh Pourbadakhshan
17 shahrivar 5
Mashhad Iran (Islamic Republic of) 9166655688 +98 51 3859 6431 pourbadakhshann@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients under 18 who are diagnosed with PFAPA based on the Marshall Cratria by a pediatric rheumatologist. 1 month 18 years Both 1-Dissatisfaction of parents to participate in the project ,2-All patients with overlap syndrome R50 recurrent fever Treatment - Drugs Placebo Intervention group: In addition to the previously used treatments, treatment with lactogam (manufactured by Bio Fermentation 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. Control group: 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 disease attacks in case and control groups. Timepoint: Monthly. Method of measurement: Clinical examination and completion of checklist. Mashhad University of Medical Sciences Approved 2021-08-31 Ethics committee of Mashhad University of Medical Sciences Namaz Blvd , Akbar hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)