A Phase III, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Efficacy and Safety of Probiotics eN-Lac® Capsules (Lactobacillus Paracasei GMNL-32) for the Treatment of Children With Perennial Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) in children with perennial allergic rhinitis.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects in age of 5-16 years old
- •Subjects with a history of perennial allergic rhinitis for at least 1 year.
- •Subjects with anyone of the following allergy test results (test results within 12 months before study are acceptable)
- •Skin-Prick test:
- •Wheal diameter 3 mm larger than the negative control (salt water) and at least 1/2 the diameter of the positive control (histamine)
- •Positive reaction determined by the CAP system Positive reaction defined as CAP score≥2
- •Positive reaction determined by the MAST system Positive reaction defined as MAST score≥1
- •Subject's mean nasal total symptom score (NTSS) throughout the screening period (4 to 10 days) should be ≥ 5 and ≤ 10; at least 3 days should be recorded during the screening period
- •Subjects' parents or their legally acceptable representatives have signed the informed consent form.
排除标准
- •Subjects have clinically significant laboratory abnormality results (hematology, biochemistry or urinalysis tests) as determined by the investigator (tests performed during 14 days prior to visit 1 or during baseline period can be used for evaluating those criteria).
- •Subjects with acute or significant chronic sinusitis, severe persistent asthma, congenital immunodeficiency, massive wound in oral cavity, use of rhinitis medications, neuropsychiatric disorders, immunocompromised, or chronic use of tricyclic antidepressants.
- •Subjects need to take prohibited medications during the study or take the medications within the corresponding time frame indicated prior to the screening visit:
- •Parenteral or oral corticosteroids 30 days Nasal corticosteroids 30 days Topical use of flurandrenolide 30 days Topical use of clobetasol propionate 30 days Topical use of halobetasol propionate 30 days Astemizole 30 days Ketotifene 21 days Nedocromil or Sodium cromoglycate 14 days Loratadine 10 days Cetirizine 7 days Antileukotrienes 7 days Other H1 antihistamine 3 days Nasal decongestant 3 days Any food supplements including probiotics 3 days
- •Subjects are undergoing desensitization therapy within 3 months prior to the screening period or subjects with vasomotor rhinitis.
- •Subjects have participated investigational drug trial within 4 weeks before entering this study.
- •Subjects are pregnant, lactating or planning to become pregnant.
- •Subjects with any other serious diseases considered by the investigator that could interfere with the performance of NTSS result.
- •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- •Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
研究组 & 干预措施
eN-Lac® Capsules
干预措施: eN-Lac® (Biological)
Placebo Capsules
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) in children with perennial allergic rhinitis.
时间窗: NTSS is recorded daily on subject's DRC (daily record card) at the 8th week from baseline.
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.
次要结局
- 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.(at 8th week from basline)