Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens (BionAtlanta)
|ClinicalTrials.gov Identifier: NCT01096615|
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : July 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis||Dietary Supplement: Placebo Dietary Supplement: Lactobacillus paracasei LP-33||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||April 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Active Comparator: Tested product: Lactobacillus paracasei LP-33
Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table
Dietary Supplement: Lactobacillus paracasei LP-33
Placebo Comparator: Comparative product : placebo
Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table .
Dietary Supplement: Placebo
- capsule size 3
Composition of the product:
Composition of the capsule:
Products are packaged in aluminium tubes of 30 capsules.
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.
- The primary criterion is the RQLQ global score measured at the end of Week 0 and Week 5. [ Time Frame: Week 0 and Week 5 ]
The RQLQ includes 28 questions (completed between 10-15 min). Subjects are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale (0 = no impairment, 6 = severe impairment). The RQLQ score ranges from 0 to 6. This questionnaire will be filled in by volunteers on D0 and D35.
The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.
- To show a decrease in allergic rhinitis symptoms on the 5th week of product consumption (as assessed by RQLQ and RTSS-5) [ Time Frame: Week 0-Week 5 ]
- To show an increase in the time of 1st exacerbation of symptoms of rhinitis symptom with Lactobacillus paracasei LP-33 [ Time Frame: Week 5- Week 7 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096615
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|Study Chair:||Jean BOUSQUET, Pr|