The purpose of this study is to evaluate the efficacy and safety of probiotics eN-Lac® capsules (Lactobacillus paracasei GMNL-32) for the treatment of children with perennial allergic rhinitis(PAR).
This study is PhaseIII clinical trial. According the results of PhaseII study,we find out the optimal dose and its maximum effectiveness in relieving the nasal symptoms of eN-Lac® (Lactobacillus paracasei GMNL-32) in children with PAR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
236
Taipei City Hospital Renai Branch
Taipei, Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taipei, Taiwan
Chang Gung Children's Hospital
Taipei, Taipei, Taiwan
Cardinal Tien Hospital
Xindian, Taipei, Taiwan
Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) in children with perennial allergic rhinitis.
NTSS is determined by the severity of allergic symptoms, including sneezing, rhinorrhea, nasal itching, and nasal stuffiness. These symptoms are evaluated using a four-point scale, namely, 0 = Absent, 1 = Mild (present but not disturbing), 2 = Moderate (disturbing but not hampering daytime activities and/or sleep), 3 = Severe (hampering daytime activities and/or sleep). NTSS is calculated by the sum of the scores of the symptoms.
Time frame: NTSS is recorded daily on subject's DRC (daily record card) at the 8th week from baseline.
The safety features are evaluated through the changes of vital signs, physical examinations, laboratory test result (hematology, biochemistry and urinalysis tests), as well as the occurrence of adverse event.
The incidence of adverse events will be categorized by severity and related to the time of occurrence. Changes in physical examinations, changes in laboratory test results (hematology, biochemistry and urinalysis tests) from screening period, and change of vital signs will be summarized and analyzed by the descriptive statistics.
Time frame: at 8th week from basline
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