Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens
NCT ID: NCT01096615
Last Updated: 2012-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2010-04-30
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Lactobacillus paracasei LP-33
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.
Comparative product : placebo
Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table .
Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
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.
Lactobacillus paracasei LP-33
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chr Hansen
INDUSTRY
Merck Medication Familiale
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean BOUSQUET, Pr
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Emmanuel DEJOUX
Béziers, , France
Gabriel VENTURINI
Béziers, , France
Nicolas BRETON
Béziers, , France
Robert COMBET
Béziers, , France
Thierry STEFANAGGI
Béziers, , France
Olivier BISCH
Bischeim, , France
Sabine GRUTTER
Bischeim, , France
Sophie ROSENBERG
Bischeim, , France
Jacques RAMBAUD
Bompas, , 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
François LE HINGRAT
Calvisson, , 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
Marcel RUETSCH
Dessenheim, , France
Christian DAUGENET
Équeurdreville-Hainneville, , France
Gérard DUGNY
Évreux, , France
Thierry CANALI
Évreux, , France
Frédéric RENOU
Fécamp, , 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-Têt, , France
Reinhard RENNER
Laroque-des-Albères, , France
Christian FLAISSIER
Lasalle, , France
Irène LAFONT
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
Mèze, , 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
Nîmes, , France
Paul REGNIER-VIGOUROUX
Nîmes, , France
Claude BERNAT
Nîmes, , France
Dominique BLOT
Nîmes, , France
Marie Christine BONS-GALLET
Nîmes, , France
Philippe IMBERT
Nîmes, , 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
Gérard BOURREL
Perpignan, , France
Serge ELIE
Pompignan, , France
Sonia COURTOIS
Pont-de-l'Arche, , France
Bernard GABBAI
Pont-Saint-Esprit, , France
Geneviève DURANT
Rivesaltes, , France
Baudoin PINSON
Rouen, , France
Olivier BAISSAS
Rouen, , France
Dominique GENOUD
Rousson, , France
Sylvie OLLIVIER
Rousson, , France
Patrick VERDAVOINE
Rugles, , France
Béatrice LOGNOS-FOLCO
Saint-Georges-dOrques, , France
Catherine MERCEY
Saint-Génis-des-Fontaines, , France
Yves MERCEY
Saint-Génis-des-Fontaines, , France
Jean-Yves DOERR
Saint-Sébastien-de-Morsent, , France
Martine FERRE
Saint-Siffret, , France
Gil MEYRAND
Sainte-Anastasie, , France
Jean Baptiste THIBERT
Salses-le-Château, , France
Léa ABOAF
Schilttigheim, , France
Monique LESCOUTE
Schilttigheim, , France
Raymond ATTUIL
Schilttigheim, , France
Luc ECHINARD
Sète, , France
Laurent TENNEZE
Sommières, , France
Charles LOUSQUI
Strasbourg, , France
Claire PFRUNNER-SCHNEIDER
Strasbourg, , France
Claire ROLLAND-JACQUEMIN
Strasbourg, , France
Hélène STURCHLER
Strasbourg, , France
Joël ETIENNEZ
Strasbourg, , France
Judah TOLEDANO
Strasbourg, , France
Nathan ABENHAIM
Strasbourg, , France
Patrick KORMANN
Strasbourg, , France
Philippe MARMOR
Strasbourg, , France
Roland BENEDIC
Strasbourg, , France
Véronique PEREZ
Strasbourg, , France
Maxime BOUMANDIL
Strasbourg, , France
Hervé MOREL
Tilly-sur-Seulles, , France
Bernard CLARY
Trèbes, , France
Jacques GRAVES
Trèbes, , France
Christian GIRARD
Uchaud, , France
Eric LIOTARD
Uchaud, , France
Olivier CHAIX
Uzès, , France
François BAYLE
Valleraugue, , France
Philippe BOISSON
Villé, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13609
Identifier Type: -
Identifier Source: org_study_id