Clinical trial NCT01096615: Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Keywords: Allergic rhinitis-Probiotic Lactobacillus paracasei LP-33-
Lead sponsor: Merck Medication Familiale
Sponsor class: INDUSTRY
Collaborators: name: Chr Hansen
First posted: 2010-03-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: The primary criterion is the RQLQ global score measured at the end of Week 0 and Week 5.
timeFrame: Week 0 and Week 5
Secondary outcomes:
measure: To show a decrease in allergic rhinitis symptoms on the 5th week of product consumption (as assessed by RQLQ and RTSS-5)
timeFrame: Week 0-Week 5
measure: To show an increase in the time of 1st exacerbation of symptoms of rhinitis symptom with Lactobacillus paracasei LP-33
timeFrame: Week 5- Week 7
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Corinne SION
city: Ales
country: France
facility: Alain FAUDIN
city: Ales
country: France
facility: Philippe PIAT
city: Ales
country: France
facility: Sylvie CHABROL-RIVIERE
city: Aubevoye
country: France
facility: Daniel FERET
city: Aubord
country: France
facility: Florian KOMAC
city: Avoine
country: France
facility: Alain GIACOMINO
city: Beaucaire
country: France
facility: Jean DEFLAUX
city: Beauvoisin
country: France
facility: Sébastien CONVENT
city: Beziers
country: France
facility: Catherine BRUNET-CAZOT
city: Beziers
country: France
facility: Emmanuel DEJOUX
city: Beziers
country: France
facility: Gabriel VENTURINI
city: Beziers
country: France
facility: Nicolas BRETON
city: Beziers
country: France
facility: Robert COMBET
city: Beziers
country: France
facility: Thierry STEFANAGGI
city: Bischeim
country: France
facility: Olivier BISCH
city: Bischeim
country: France
facility: Sabine GRUTTER
city: Bischeim
country: France
facility: Sophie ROSENBERG
city: Bompas
country: France
facility: Jacques RAMBAUD
city: Bouillargues
country: France
facility: Chantal MARTIN
city: Boujan Sur Libron
country: France
facility: Catherine AYRAL
city: Bourg Achard
country: France
facility: Laurence DAGES
city: Bretteville L'orgueilleuse
country: France
facility: Dominique EDET
city: Broglie
country: France
facility: Didier CADINOT
city: Calvisson
country: France
facility: François LE HINGRAT
city: Castelnau Le Lez
country: France
facility: Bernadette CHAUFFAILLE
city: Castelnaudary
country: France
facility: Georges BINET
city: Castelnaudary
country: France
facility: Hervé VILAREM
city: Clarensac
country: France
facility: Gladys HAVARD
city: Clarensac
country: France
facility: Marc GARCIA
city: Codognan
country: France
facility: Michel AMOUYAL
city: Codognan
country: France
facility: Nicole FERRIER
city: Colombelles
country: France
facility: Philippe GRUJARD
city: Cournonsec
country: France
facility: Philippe HEUZE
city: Cournonterrac
country: France
facility: Gregoire MARTOCQ
city: Coursan
country: France
facility: Bruno DAUBIN
city: Damville
country: France
facility: Jean-Baptiste DE LEMOS
city: Dessenheim
country: France
facility: Marcel RUETSCH
city: Equeurdreville Hainneville
country: France
facility: Christian DAUGENET
city: Evreux
country: France
facility: Gérard DUGNY
city: Evreux
country: France
facility: Thierry CANALI
city: Fecamp
country: France
facility: Frédéric RENOU
city: Fleury Sur Orne
country: France
facility: Pascal MABIRE
city: Gambsheim
country: France
facility: Alain LION
city: Hangenbieten
country: France
facility: Raymond WESTERFELD
city: Hautot Sur Mer
country: France
facility: Gérard TELLIER
city: Herlisheim
country: France
facility: Marc BUR
city: Ille Sur Tet
country: France
facility: Jean Pascal SASTOURNE
city: Laroque Des Alberes
country: France
facility: Reinhard RENNER
city: Lasalle
country: France
facility: Christian FLAISSIER
city: Lasalle
country: France
facility: Irène LAFONT
city: Le Cailar
country: France
facility: Patrick DUTILLEUL
city: Lignan Sur Orb
country: France
facility: Claude BRUNAUD
city: Lingolsheim
country: France
facility: Jean-Philippe RICHTER
city: Marguerittes
country: France
facility: Stéphane BOURGHOL
city: Maurin
country: France
facility: Maurice GAY
city: Meze
country: France
facility: Patrick OLOMBEL
city: Montpellier
country: France
facility: Cécile BELIN-SAUGET
city: Montpellier
country: France
facility: Jean François GUILLEM
city: Montpellier
country: France
facility: Jean Roch ALEA
city: Montpellier
country: France
facility: Marie Pascale DEMOLY
city: Montpellier
country: France
facility: MONGIN
city: Montpellier
country: France
facility: Thierry AUTARD
city: Montpellier
country: France
facility: Victor BASTIDE
city: Montpellier
country: France
facility: Michel CHASSAGNE
city: Montpellier
country: France
facility: Philippe CAYRON
city: Montpellier
country: France
facility: Jean Pierre CANO
city: Mulhouse
country: France
facility: Patrick VOGT
city: Mundolsheim
country: France
facility: Jean-Louis WURTZ
city: Nimes
country: France
facility: Nasser GOUCHENE
city: Nimes
country: France
facility: Paul REGNIER-VIGOUROUX
city: Nimes
country: France
facility: Claude BERNAT
city: Nimes
country: France
facility: Dominique BLOT
city: Nimes
country: France
facility: Marie Christine BONS-GALLET
city: Nimes
country: France
facility: Philippe IMBERT
city: Nîmes
country: France
facility: COSTA
city: Obernai
country: France
facility: Georgios MARKIDIS
city: Obernai
country: France
facility: Natacha HEITZ
city: Obernai
country: France
facility: Yves-Olivier SCHLECHT
city: Ottrott
country: France
facility: Guy BIRRY
city: Pacy Sur Eure
country: France
facility: Bernard PRIJAC
city: Perpignan
country: France
facility: Alain GUERRI
city: Perpignan
country: France
facility: Chantal MALZAC
city: Perpignan
country: France
facility: Gérard BOURREL
city: Pompignan
country: France
facility: Serge ELIE
city: Pont de L'arche
country: France
facility: Sonia COURTOIS
city: Pont Saint Esprit
country: France
facility: Bernard GABBAI
city: Rivesaltes
country: France
facility: Geneviève DURANT
city: Rouen
country: France
facility: Baudoin PINSON
city: Rouen
country: France
facility: Olivier BAISSAS
city: Rousson
country: France
facility: Dominique GENOUD
city: Rousson
country: France
facility: Sylvie OLLIVIER
city: Rugles
country: France
facility: Patrick VERDAVOINE
city: Saint Genis Des Fontaines
country: France
facility: Catherine MERCEY
city: Saint Genis Des Fontaines
country: France
facility: Yves MERCEY
city: Saint Georges D'orques
country: France
facility: Béatrice LOGNOS-FOLCO
city: Saint Sebastien de Morsent
country: France
facility: Jean-Yves DOERR
city: Saint Siffret
country: France
facility: Martine FERRE
city: Sainte Anastasie
country: France
facility: Gil MEYRAND
city: Salses Le Chateau
country: France
facility: Jean Baptiste THIBERT
city: Schilttigheim
country: France
facility: Léa ABOAF
city: Schilttigheim
country: France
facility: Monique LESCOUTE
city: Schilttigheim
country: France
facility: Raymond ATTUIL
city: Sete
country: France
facility: Luc ECHINARD
city: Sommieres
country: France
facility: Laurent TENNEZE
city: Strasbourg
country: France
facility: Charles LOUSQUI
city: Strasbourg
country: France
facility: Claire PFRUNNER-SCHNEIDER
city: Strasbourg
country: France
facility: Claire ROLLAND-JACQUEMIN
city: Strasbourg
country: France
facility: Hélène STURCHLER
city: Strasbourg
country: France
facility: Joël ETIENNEZ
city: Strasbourg
country: France
facility: Judah TOLEDANO
city: Strasbourg
country: France
facility: Nathan ABENHAIM
city: Strasbourg
country: France
facility: Patrick KORMANN
city: Strasbourg
country: France
facility: Philippe MARMOR
city: Strasbourg
country: France
facility: Roland BENEDIC
city: Strasbourg
country: France
facility: Véronique PEREZ
city: Strasbourg
country: France
facility: Maxime BOUMANDIL
city: Tilly Sur Seulles
country: France
facility: Hervé MOREL
city: Trebes
country: France
facility: Bernard CLARY
city: Trebes
country: France
facility: Jacques GRAVES
city: Uchaud
country: France
facility: Christian GIRARD
city: Uchaud
country: France
facility: Eric LIOTARD
city: Uzes
country: France
facility: Olivier CHAIX
city: Valleraugue
country: France
facility: François BAYLE
city: Ville
country: France
facility: Philippe BOISSON
Study officials:
name: Jean BOUSQUET, Pr
role: STUDY_CHAIR
References: