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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by GenMont Biotech Incorporation
Sponsor:
Collaborator:
Biomedical Development Corporation
Information provided by (Responsible Party):
GenMont Biotech Incorporation
ClinicalTrials.gov Identifier:
NCT01116778
First received: April 30, 2010
Last updated: June 24, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Perennial Allergic Rhinitis
Probiotics
Lactobacillus Paracasei GMNL-32 (eN-Lac®)
Biological: eN-Lac®
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GenMont Biotech Incorporation:

Primary Outcome Measures:
  • Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) in children with perennial allergic rhinitis. [ Time Frame: NTSS is recorded daily on subject's DRC (daily record card) at the 8th week from baseline. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: at 8th week from basline ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eN-Lac® Capsules Biological: eN-Lac®
One capsule with 2x10^9 colony forming unit (cfu) LP GMNL-32, once daily, po
Other Name: eN-Lac® Capsules (Lactobacillus paracasei GMNL-32)
Placebo Capsules Other: Placebo
One placebo capsule, once daily, po
Other Name: Placebo Capsules

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

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116778

Contacts
Contact: Shyh-Dar Shyur, M.D. abc4540@gmail.com
Contact: Zeing Liao, master 886-6-505-2151 ext 325 zeing@genmont.com.tw

Locations
Taiwan
Cardinal Tien Hospital Recruiting
Xindian, Taipei, Taiwan, 231
Contact: Leticia B. Sy., M.D.       dikoletty@yahoo.com   
Principal Investigator: Leticia B. Sy., M.D.         
MacKay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Contact: Shyh-Dar Shyur, M.D.       abc4540@gmail.com   
Principal Investigator: Shyh-Dar Shyur, M.D.         
Chang Gung Children's Hospital Recruiting
Taipei, Taiwan, 105
Contact: Dah-Chin Yan, M.D.       A5291@adm.cgmh.com.tw   
Principal Investigator: Dah-Chin Yan, M.D.         
Taipei City Hospital Renai Branch Recruiting
Taipei, Taiwan, 10341
Contact: Wei-Fong Wu, M.D.       DAB55@tpech.gov.tw   
Principal Investigator: Wei-Fong Wu, M.D.         
Sponsors and Collaborators
GenMont Biotech Incorporation
Biomedical Development Corporation
Investigators
Study Director: Ying-Chen Lu, PhD GenMont Biothech Incorporation
  More Information

No publications provided

Responsible Party: GenMont Biotech Incorporation
ClinicalTrials.gov Identifier: NCT01116778     History of Changes
Other Study ID Numbers: MA0809005101
Study First Received: April 30, 2010
Last Updated: June 24, 2012
Health Authority: Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by GenMont Biotech Incorporation:
perennial allergic rhinitis
probiotics
Lactobacillus paracasei GMNL-32 (eN-Lac®)
efficacy and safety

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014