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

NCT01116778 | Completed Phase 3 DMC

• 1 other identifier: MA0809005101
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 4

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).

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) 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.

Secondary Outcomes (1)

• 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.

  at 8th week from basline

Study Arms (2)

eN-Lac® Capsules

EXPERIMENTAL

Biological: eN-Lac®

Placebo Capsules

OTHER

Other: Placebo

Interventions

eN-Lac® BIOLOGICAL

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

Also known as: eN-Lac® Capsules (Lactobacillus paracasei GMNL-32)

eN-Lac® Capsules

Placebo OTHER

One placebo capsule, once daily, po

Also known as: Placebo Capsules

Placebo Capsules

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GenMont Biotech Incorporation: lead
• Biomedical Development Corporation: collaborator

Study Sites (4)

Taipei City Hospital Renai Branch

Taipei, Taipei, 10341, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taipei, 10449, Taiwan

Location

Chang Gung Children's Hospital

Taipei, Taipei, 105, Taiwan

Location

Cardinal Tien Hospital

Xindian, Taipei, 231, Taiwan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ying-Chen Lu, PhD

  GenMont Biothech Incorporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

TW (4)