NCT01096615

Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens

Evaluation of the Effect of Probiotic Lactobacillus Paracasei Lp-33 for the Management of Rhinitis in People Sensitized to Allergens. A Double Blind Randomized Parallel Placebo Controlled Study. (GA2LEN STUDY) BIONATLANTA Project

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Merck Medication Familiale · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.

Detailed description

Oral H1-antihistamines are first treatment recommended for allergic rhinitis (Bousquet et al, 2008) however they do not completely alleviate symptoms. This new study will therefore assess the effect of Lactobacillus paracasei LP-33 in the management of nasal and ocular symptoms, in addition to H1-antihistamines treatment. The main objective is to evaluate the effect of Lactobacillus paracasei LP-33 on quality of life. Additionally allergic rhinitis symptoms (nasal and eye symptoms) and immunological parameters will be evaluated, before and during the supplementation. Lactobacillus paracasei LP-33 is targeting the general population and improving quality of life of people sensitized to allergens. The study will be conducted in Europe on adult subjects with persistent allergic rhinitis.

Conditions

• Rhinitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Description: \- capsule size 3 Composition of the product: * 45 mg of microcristalline cellulose, * 132 mg of maltodextrin, * 3 mg of magnesium stearate. Composition of the capsule: * 46 mg of hypromellose, * 1 mg of titanium dioxide. Packaging: Products are packaged in aluminium tubes of 30 capsules. Storage: The product should be stored in a fridge. Direction for use: subject should consume 1 capsule daily together with a meal, with a glass of water. The study products will be consumed daily for 7 weeks.
DIETARY_SUPPLEMENT	Lactobacillus paracasei LP-33	Description: * minimum 2.0x109 CFU of Lactobacillus paracasei LP-33 * capsule size 3 1 capsule daily together with a meal, with a glass of water.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-03-31
• Last updated: 2012-07-26

Locations

125 sites across 1 country: France