the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis (PAR)

GenMont Biotech

Status and phase

Completed

Phase 3

Conditions

Perennial Allergic Rhinitis

Lactobacillus Paracasei GMNL-32 (eN-Lac®)

Probiotics

Treatments

Biological: eN-Lac®

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01116778

MA0809005101

Details and patient eligibility

About

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).

Full 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.

Enrollment

236 patients

Sex

All

Ages

5 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.