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

NCT ID: NCT01116778

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-06-30

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.

Conditions

Perennial Allergic Rhinitis; Probiotics; Lactobacillus Paracasei GMNL-32 (eN-Lac®)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

eN-Lac® Capsules

Group Type: EXPERIMENTAL

eN-Lac®

Intervention Type: BIOLOGICAL

One capsule with 2x10\^9 colony forming unit (cfu) LP GMNL-32, once daily, po

Placebo Capsules

Group Type: OTHER

Placebo

Intervention Type: OTHER

One placebo capsule, once daily, po

Interventions

eN-Lac®

One capsule with 2x10\^9 colony forming unit (cfu) LP GMNL-32, once daily, po

Intervention Type: BIOLOGICAL

Placebo

One placebo capsule, once daily, po

Intervention Type: OTHER

Other Intervention Names

eN-Lac® Capsules (Lactobacillus paracasei GMNL-32); Placebo Capsules

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Development Corporation

INDUSTRY

Sponsor Role: collaborator

GenMont Biotech Incorporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying-Chen Lu, PhD

Role: STUDY_DIRECTOR

GenMont Biothech Incorporation

Locations

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

Countries

Taiwan

Other Identifiers

MA0809005101

Identifier Type: -

Identifier Source: org_study_id