Clinical trial NCT01116778: the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Probiotics
Lactobacillus Paracasei GMNL-32 (eN-Lac®)
Keywords: perennial allergic rhinitis
probiotics
Lactobacillus paracasei GMNL-32 (eN-Lac®)
efficacy and safety
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Development Corporation
First posted: 2010-05-05
Enrollment: 236
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) in children with perennial allergic rhinitis.
timeFrame: NTSS is recorded daily on subject's DRC (daily record card) at the 8th week from baseline.
Secondary outcomes:
measure: 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.
timeFrame: at 8th week from basline
Other outcomes:
Locations:
city: Xindian
country: Taiwan
facility: Cardinal Tien Hospital
state: Taipei
city: Taipei
country: Taiwan
facility: Taipei City Hospital Renai Branch
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Children's Hospital
Study officials:
affiliation: GenMont Biothech Incorporation
name: Ying-Chen Lu, PhD
role: STUDY_DIRECTOR
References: