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| Name | Class |
|---|---|
| Biomedical Development Corporation | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of probiotics eN-LacĀ® 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-LacĀ® (Lactobacillus paracasei GMNL-32) in children with PAR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eN-LacĀ® Capsules | Experimental |
| |
| Placebo Capsules | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eN-LacĀ® | Biological | One capsule with 2x10^9 colony forming unit (cfu) LP GMNL-32, once daily, po |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-LacĀ®) 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. | NTSS is recorded daily on subject's DRC (daily record card) at the 8th week from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Wheal diameter 3 mm larger than the negative control (salt water) and at least 1/2 the diameter of the positive control (histamine)
Exclusion Criteria
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
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| Name | Affiliation | Role |
|---|---|---|
| Ying-Chen Lu, PhD | GenMont Biothech Incorporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei City Hospital Renai Branch | Taipei | Taipei | 10341 | Taiwan | ||
| MacKay Memorial Hospital |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Other | One placebo capsule, once daily, po |
|
|
| at 8th week from basline |
| Taipei |
| Taipei |
| 10449 |
| Taiwan |
| Chang Gung Children's Hospital | Taipei | Taipei | 105 | Taiwan |
| Cardinal Tien Hospital | Xindian | Taipei | 231 | Taiwan |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |