NCT01116778

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: GenMont Biotech Incorporation · Industry
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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®)

Interventions

Type	Name	Description
BIOLOGICAL	eN-Lac®	One capsule with 2x10\^9 colony forming unit (cfu) LP GMNL-32, once daily, po
OTHER	Placebo	One placebo capsule, once daily, po

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2010-05-05
• Last updated: 2015-09-02

Locations

4 sites across 1 country: Taiwan