Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens
BionAtlanta
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
1 other identifier
interventional
500
1 country
125
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2010
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJuly 26, 2012
July 1, 2012
1.4 years
March 30, 2010
July 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 0 and Week 5
Secondary Outcomes (2)
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
Study Arms (2)
Tested product: Lactobacillus paracasei LP-33
ACTIVE COMPARATOREach patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table
Comparative product : placebo
PLACEBO COMPARATOREach patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table .
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Medication Familialelead
- Chr Hansen A/Scollaborator
Study Sites (125)
Corinne SION
Aix-en-Provence, 13100, France
Alain FAUDIN
Alès, 30100, France
Philippe PIAT
Alès, 30100, France
Sylvie CHABROL-RIVIERE
Alès, 30100, France
Daniel FERET
Aubevoye, 27940, France
Florian KOMAC
Aubord, 30620, France
Alain GIACOMINO
Avoine, 37420, France
Jean DEFLAUX
Beaucaire, 30300, France
Sébastien CONVENT
Beauvoisin, 30640, France
Catherine BRUNET-CAZOT
Béziers, 34500, France
Emmanuel DEJOUX
Béziers, 34500, France
Gabriel VENTURINI
Béziers, 34500, France
Nicolas BRETON
Béziers, 34500, France
Robert COMBET
Béziers, 34500, France
Thierry STEFANAGGI
Béziers, 34500, France
Olivier BISCH
Bischeim, 67800, France
Sabine GRUTTER
Bischeim, 67800, France
Sophie ROSENBERG
Bischeim, 67800, France
Jacques RAMBAUD
Bompas, 66430, France
Chantal MARTIN
Bouillargues, 30230, France
Catherine AYRAL
Boujan-sur-Libron, 34760, France
Laurence DAGES
Bourg-Achard, 27310, France
Dominique EDET
Bretteville-l'Orgueilleuse, 14740, France
Didier CADINOT
Broglie, 27270, France
François LE HINGRAT
Calvisson, 30420, France
Bernadette CHAUFFAILLE
Castelnau-le-Lez, 34170, France
Georges BINET
Castelnaudary, 11400, France
Hervé VILAREM
Castelnaudary, 11400, France
Gladys HAVARD
Clarensac, 30870, France
Marc GARCIA
Clarensac, 30870, France
Michel AMOUYAL
Codognan, 30920, France
Nicole FERRIER
Codognan, 30920, France
Philippe GRUJARD
Colombelles, 14460, France
Philippe HEUZE
Cournonsec, 34660, France
Gregoire MARTOCQ
Cournonterrac, 34660, France
Bruno DAUBIN
Coursan, 11110, France
Jean-Baptiste DE LEMOS
Damville, 27240, France
Marcel RUETSCH
Dessenheim, 68600, France
Christian DAUGENET
Équeurdreville-Hainneville, 50120, France
Gérard DUGNY
Évreux, 27000, France
Thierry CANALI
Évreux, 27000, France
Frédéric RENOU
Fécamp, 76400, France
Pascal MABIRE
Fleury-sur-Orne, 14123, France
Alain LION
Gambsheim, 67760, France
Raymond WESTERFELD
Hangenbieten, 67980, France
Gérard TELLIER
Hautot-sur-Mer, 76550, France
Marc BUR
Herlisheim, 67850, France
Jean Pascal SASTOURNE
Ille-sur-Têt, 66130, France
Reinhard RENNER
Laroque-des-Albères, 66740, France
Christian FLAISSIER
Lasalle, 30460, France
Irène LAFONT
Lasalle, 30460, France
Patrick DUTILLEUL
Le Cailar, 30740, France
Claude BRUNAUD
Lignan-sur-Orb, 34490, France
Jean-Philippe RICHTER
Lingolsheim, 67380, France
Stéphane BOURGHOL
Marguerittes, 30320, France
Maurice GAY
Maurin, 34970, France
Patrick OLOMBEL
Mèze, 34140, France
Cécile BELIN-SAUGET
Montpellier, 30090, France
Jean François GUILLEM
Montpellier, 34000, France
Jean Roch ALEA
Montpellier, 34000, France
Marie Pascale DEMOLY
Montpellier, 34000, France
MONGIN
Montpellier, 34000, France
Thierry AUTARD
Montpellier, 34000, France
Victor BASTIDE
Montpellier, 34000, France
Michel CHASSAGNE
Montpellier, 34070, France
Philippe CAYRON
Montpellier, 34070, France
Jean Pierre CANO
Montpellier, 34080, France
Patrick VOGT
Mulhouse, 68200, France
Jean-Louis WURTZ
Mundolsheim, 67450, France
Nasser GOUCHENE
Nîmes, 30000, France
Paul REGNIER-VIGOUROUX
Nîmes, 30000, France
Claude BERNAT
Nîmes, 30900, France
Dominique BLOT
Nîmes, 30900, France
Marie Christine BONS-GALLET
Nîmes, 30900, France
Philippe IMBERT
Nîmes, 30900, France
COSTA
Nîmes, 30920, France
Georgios MARKIDIS
Obernai, 67210, France
Natacha HEITZ
Obernai, 67210, France
Yves-Olivier SCHLECHT
Obernai, 67210, France
Guy BIRRY
Ottrott, 67530, France
Bernard PRIJAC
Pacy-sur-Eure, 27120, France
Alain GUERRI
Perpignan, 66000, France
Chantal MALZAC
Perpignan, 66000, France
Gérard BOURREL
Perpignan, 66000, France
Serge ELIE
Pompignan, 30170, France
Sonia COURTOIS
Pont-de-l'Arche, 27340, France
Bernard GABBAI
Pont-Saint-Esprit, 30130, France
Geneviève DURANT
Rivesaltes, 66600, France
Baudoin PINSON
Rouen, 76000, France
Olivier BAISSAS
Rouen, 76000, France
Dominique GENOUD
Rousson, 30340, France
Sylvie OLLIVIER
Rousson, 30340, France
Patrick VERDAVOINE
Rugles, 27250, France
Béatrice LOGNOS-FOLCO
Saint-Georges-dOrques, 34680, France
Catherine MERCEY
Saint-Génis-des-Fontaines, 66740, France
Yves MERCEY
Saint-Génis-des-Fontaines, 66740, France
Jean-Yves DOERR
Saint-Sébastien-de-Morsent, 27180, France
Martine FERRE
Saint-Siffret, 30700, France
Gil MEYRAND
Sainte-Anastasie, 30190, France
Jean Baptiste THIBERT
Salses-le-Château, 66600, France
Léa ABOAF
Schilttigheim, 67300, France
Monique LESCOUTE
Schilttigheim, 67300, France
Raymond ATTUIL
Schilttigheim, 67300, France
Luc ECHINARD
Sète, 34200, France
Laurent TENNEZE
Sommières, 30250, France
Charles LOUSQUI
Strasbourg, 67000, France
Claire PFRUNNER-SCHNEIDER
Strasbourg, 67000, France
Claire ROLLAND-JACQUEMIN
Strasbourg, 67000, France
Hélène STURCHLER
Strasbourg, 67000, France
Joël ETIENNEZ
Strasbourg, 67000, France
Judah TOLEDANO
Strasbourg, 67000, France
Nathan ABENHAIM
Strasbourg, 67000, France
Patrick KORMANN
Strasbourg, 67000, France
Philippe MARMOR
Strasbourg, 67000, France
Roland BENEDIC
Strasbourg, 67000, France
Véronique PEREZ
Strasbourg, 67000, France
Maxime BOUMANDIL
Strasbourg, 67100, France
Hervé MOREL
Tilly-sur-Seulles, 14250, France
Bernard CLARY
Trèbes, 11800, France
Jacques GRAVES
Trèbes, 11800, France
Christian GIRARD
Uchaud, 30620, France
Eric LIOTARD
Uchaud, 30620, France
Olivier CHAIX
Uzès, 30700, France
François BAYLE
Valleraugue, 30570, France
Philippe BOISSON
Villé, 67220, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean BOUSQUET, Pr
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2010
First Posted
March 31, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
July 26, 2012
Record last verified: 2012-07