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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
500
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.
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.
The primary criterion is the RQLQ global score measured at the end of 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.
Time frame: Week 0 and Week 5
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
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Corinne SION
Aix-en-Provence, France
Alain FAUDIN
Alès, France
Philippe PIAT
Alès, France
Sylvie CHABROL-RIVIERE
Alès, France
Daniel FERET
Aubevoye, France
Florian KOMAC
Aubord, France
Alain GIACOMINO
Avoine, France
Jean DEFLAUX
Beaucaire, France
Sébastien CONVENT
Beauvoisin, France
Catherine BRUNET-CAZOT
Béziers, France
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