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

Phase 3

Completed

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

• Registration Number: NCT01116778
• Lead Sponsor: GenMont Biotech Incorporation

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.

Study Timeline

• Study First Submitted: 2010-04-30
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Primary Completion: 2012-01
• Study Completion: 2012-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy profile of probiotics Lactobacillus paracasei GMNL-32 (eN-Lac®) in children with perennial allergic rhinitis.	NTSS is recorded daily on subject's DRC (daily record card) at the 8th week from baseline.	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

Name	Time	Method
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	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.

Trial Locations

Locations (4)

Cardinal Tien Hospital; 🇨🇳 Xindian, Taipei, Taiwan

Taipei City Hospital Renai Branch; 🇨🇳 Taipei, Taiwan

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Children's Hospital; 🇨🇳 Taipei, Taiwan