Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens
- Conditions
- Rhinitis
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Lactobacillus paracasei LP-33
- Registration Number
- NCT01096615
- Lead Sponsor
- Merck Medication Familiale
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Male and female subjects;
- Aged 18 to 60 years;
- People with nasal and ocular discomfort at least sensitized to grass pollen;
- Subject with PER allergy (persistent form) as defined by ARIA guidelines or with a recurrent history of seasonal allergic rhinitis documented by treatment intakes in his medical dossier.
- Previous positive skin prick test or presence of specific serum IgE antibodies class II or above against timothy grass in the last 5 years. If no data are available, a test for detection of timothy grass specific serum IgE antibodies (Phadia CAP System) will be performed at the pre-inclusion visit;
- With RQLQ score ≥ 2;
- Subjects agree to stop consumption of probiotics (food or dietary supplement containing probiotics) and vitamins and/or minerals during the study (D-10/D-7 to D49).
Female subjects with efficient contraception and asthmatic subjects (with a controlled disease and without oral corticosteroid) can be included in the study.
The baseline period prior to treatment with Lactobacillus paracasei LP-33 is 7 days. On recommendations of the consulted experts, Pr Bousquet and Pr Hamelmann, a wash-out period of 3 additional days is recommended before baseline for subject using intranasal corticosteroid before their inclusion. As a consequence, the baseline may be extended to 10 days for these subjects In case the subject consumed an anti-H1 (other than Loratadine) before his (her) inclusion, he (she) will have to switch to Loratadine to be included.
-
Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
- Presenting a psychological incapability or having a bad comprehension of the language (French or German according to the concerned country) to understand the information letter and then to sign the informed consent;
- Refusing to sign the informed consent;
- Adult under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- Pregnant or breastfeeding women;
- Use of medication which could interfere with the study in the investigator's opinion (antibiotics, etc...);
- Subject who does not agree to stop his/her consumption of dietary supplements and foods containing probiotics and his/her supplementation of vitamins/minerals during the study (D-10/D-7 to D49).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparative product : placebo Placebo Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table . Tested product: Lactobacillus paracasei LP-33 Lactobacillus paracasei LP-33 Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table
- Primary Outcome Measures
Name Time Method The primary criterion is the RQLQ global score measured at the end of Week 0 and Week 5. 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.
- Secondary Outcome Measures
Name Time Method To show a decrease in allergic rhinitis symptoms on the 5th week of product consumption (as assessed by RQLQ and RTSS-5) Week 0-Week 5 To show an increase in the time of 1st exacerbation of symptoms of rhinitis symptom with Lactobacillus paracasei LP-33 Week 5- Week 7
Trial Locations
- Locations (125)
François LE HINGRAT
🇫🇷Calvisson, France
Béatrice LOGNOS-FOLCO
🇫🇷Saint Georges D'orques, France
Olivier BAISSAS
🇫🇷Rouen, France
Jean-Yves DOERR
🇫🇷Saint Sebastien de Morsent, France
Laurent TENNEZE
🇫🇷Sommieres, France
Sylvie OLLIVIER
🇫🇷Rousson, France
Martine FERRE
🇫🇷Saint Siffret, France
Gil MEYRAND
🇫🇷Sainte Anastasie, France
Raymond ATTUIL
🇫🇷Schilttigheim, France
Dominique GENOUD
🇫🇷Rousson, France
Véronique PEREZ
🇫🇷Strasbourg, France
Jean Baptiste THIBERT
🇫🇷Salses Le Chateau, France
Patrick VERDAVOINE
🇫🇷Rugles, France
Nathan ABENHAIM
🇫🇷Strasbourg, France
Roland BENEDIC
🇫🇷Strasbourg, France
Léa ABOAF
🇫🇷Schilttigheim, France
Catherine MERCEY
🇫🇷Saint Genis Des Fontaines, France
Charles LOUSQUI
🇫🇷Strasbourg, France
Yves MERCEY
🇫🇷Saint Genis Des Fontaines, France
Luc ECHINARD
🇫🇷Sete, France
Claire ROLLAND-JACQUEMIN
🇫🇷Strasbourg, France
Joël ETIENNEZ
🇫🇷Strasbourg, France
Monique LESCOUTE
🇫🇷Schilttigheim, France
Judah TOLEDANO
🇫🇷Strasbourg, France
Corinne SION
🇫🇷Aix En Provence, France
Alain FAUDIN
🇫🇷Ales, France
Philippe PIAT
🇫🇷Ales, France
Sylvie CHABROL-RIVIERE
🇫🇷Ales, France
Daniel FERET
🇫🇷Aubevoye, France
Florian KOMAC
🇫🇷Aubord, France
Alain GIACOMINO
🇫🇷Avoine, France
Sébastien CONVENT
🇫🇷Beauvoisin, France
Jean DEFLAUX
🇫🇷Beaucaire, France
Catherine BRUNET-CAZOT
🇫🇷Beziers, France
Emmanuel DEJOUX
🇫🇷Beziers, France
Gabriel VENTURINI
🇫🇷Beziers, France
Nicolas BRETON
🇫🇷Beziers, France
Robert COMBET
🇫🇷Beziers, France
Thierry STEFANAGGI
🇫🇷Beziers, France
Olivier BISCH
🇫🇷Bischeim, France
Sabine GRUTTER
🇫🇷Bischeim, France
Jacques RAMBAUD
🇫🇷Bompas, France
Sophie ROSENBERG
🇫🇷Bischeim, France
Chantal MARTIN
🇫🇷Bouillargues, France
Catherine AYRAL
🇫🇷Boujan Sur Libron, France
Laurence DAGES
🇫🇷Bourg Achard, France
Dominique EDET
🇫🇷Bretteville L'orgueilleuse, France
Didier CADINOT
🇫🇷Broglie, France
Bernadette CHAUFFAILLE
🇫🇷Castelnau Le Lez, France
Georges BINET
🇫🇷Castelnaudary, France
Hervé VILAREM
🇫🇷Castelnaudary, France
Gladys HAVARD
🇫🇷Clarensac, France
Marc GARCIA
🇫🇷Clarensac, France
Michel AMOUYAL
🇫🇷Codognan, France
Nicole FERRIER
🇫🇷Codognan, France
Philippe GRUJARD
🇫🇷Colombelles, France
Philippe HEUZE
🇫🇷Cournonsec, France
Gregoire MARTOCQ
🇫🇷Cournonterrac, France
Bruno DAUBIN
🇫🇷Coursan, France
Jean-Baptiste DE LEMOS
🇫🇷Damville, France
Thierry CANALI
🇫🇷Evreux, France
Marcel RUETSCH
🇫🇷Dessenheim, France
Christian DAUGENET
🇫🇷Equeurdreville Hainneville, France
Gérard DUGNY
🇫🇷Evreux, France
Frédéric RENOU
🇫🇷Fecamp, France
Pascal MABIRE
🇫🇷Fleury Sur Orne, France
Alain LION
🇫🇷Gambsheim, France
Raymond WESTERFELD
🇫🇷Hangenbieten, France
Gérard TELLIER
🇫🇷Hautot Sur Mer, France
Marc BUR
🇫🇷Herlisheim, France
Jean Pascal SASTOURNE
🇫🇷Ille Sur Tet, France
Irène LAFONT
🇫🇷Lasalle, France
Reinhard RENNER
🇫🇷Laroque Des Alberes, France
Christian FLAISSIER
🇫🇷Lasalle, France
Patrick DUTILLEUL
🇫🇷Le Cailar, France
Claude BRUNAUD
🇫🇷Lignan Sur Orb, France
Jean-Philippe RICHTER
🇫🇷Lingolsheim, France
Stéphane BOURGHOL
🇫🇷Marguerittes, France
Maurice GAY
🇫🇷Maurin, France
Patrick OLOMBEL
🇫🇷Meze, France
Cécile BELIN-SAUGET
🇫🇷Montpellier, France
Jean François GUILLEM
🇫🇷Montpellier, France
Jean Roch ALEA
🇫🇷Montpellier, France
Marie Pascale DEMOLY
🇫🇷Montpellier, France
MONGIN
🇫🇷Montpellier, France
Thierry AUTARD
🇫🇷Montpellier, France
Victor BASTIDE
🇫🇷Montpellier, France
Michel CHASSAGNE
🇫🇷Montpellier, France
Philippe CAYRON
🇫🇷Montpellier, France
Jean Pierre CANO
🇫🇷Montpellier, France
Patrick VOGT
🇫🇷Mulhouse, France
Jean-Louis WURTZ
🇫🇷Mundolsheim, France
Nasser GOUCHENE
🇫🇷Nimes, France
Paul REGNIER-VIGOUROUX
🇫🇷Nimes, France
Claude BERNAT
🇫🇷Nimes, France
Dominique BLOT
🇫🇷Nimes, France
Marie Christine BONS-GALLET
🇫🇷Nimes, France
Philippe IMBERT
🇫🇷Nimes, France
COSTA
🇫🇷Nîmes, France
Georgios MARKIDIS
🇫🇷Obernai, France
Natacha HEITZ
🇫🇷Obernai, France
Yves-Olivier SCHLECHT
🇫🇷Obernai, France
Guy BIRRY
🇫🇷Ottrott, France
Bernard PRIJAC
🇫🇷Pacy Sur Eure, France
Alain GUERRI
🇫🇷Perpignan, France
Chantal MALZAC
🇫🇷Perpignan, France
Sonia COURTOIS
🇫🇷Pont de L'arche, France
Gérard BOURREL
🇫🇷Perpignan, France
Serge ELIE
🇫🇷Pompignan, France
Bernard GABBAI
🇫🇷Pont Saint Esprit, France
Geneviève DURANT
🇫🇷Rivesaltes, France
Baudoin PINSON
🇫🇷Rouen, France
Claire PFRUNNER-SCHNEIDER
🇫🇷Strasbourg, France
Hervé MOREL
🇫🇷Tilly Sur Seulles, France
Bernard CLARY
🇫🇷Trebes, France
Hélène STURCHLER
🇫🇷Strasbourg, France
Patrick KORMANN
🇫🇷Strasbourg, France
Philippe MARMOR
🇫🇷Strasbourg, France
Maxime BOUMANDIL
🇫🇷Strasbourg, France
Jacques GRAVES
🇫🇷Trebes, France
Philippe BOISSON
🇫🇷Ville, France
Christian GIRARD
🇫🇷Uchaud, France
Eric LIOTARD
🇫🇷Uchaud, France
Olivier CHAIX
🇫🇷Uzes, France
François BAYLE
🇫🇷Valleraugue, France