- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096615
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Aix En Provence, France, 13100
- Corinne SION
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Ales, France, 30100
- Alain FAUDIN
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Ales, France, 30100
- Philippe PIAT
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Ales, France, 30100
- Sylvie CHABROL-RIVIERE
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Aubevoye, France, 27940
- Daniel FERET
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Aubord, France, 30620
- Florian KOMAC
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Avoine, France, 37420
- Alain GIACOMINO
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Beaucaire, France, 30300
- Jean DEFLAUX
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Beauvoisin, France, 30640
- Sébastien CONVENT
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Beziers, France, 34500
- Catherine BRUNET-CAZOT
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Beziers, France, 34500
- Emmanuel DEJOUX
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Beziers, France, 34500
- Gabriel VENTURINI
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Beziers, France, 34500
- Nicolas BRETON
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Beziers, France, 34500
- Robert COMBET
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Beziers, France, 34500
- Thierry STEFANAGGI
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Bischeim, France, 67800
- Olivier BISCH
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Bischeim, France, 67800
- Sabine GRUTTER
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Bischeim, France, 67800
- Sophie ROSENBERG
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Bompas, France, 66430
- Jacques RAMBAUD
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Bouillargues, France, 30230
- Chantal MARTIN
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Boujan Sur Libron, France, 34760
- Catherine AYRAL
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Bourg Achard, France, 27310
- Laurence DAGES
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Bretteville L'orgueilleuse, France, 14740
- Dominique EDET
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Broglie, France, 27270
- Didier CADINOT
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Calvisson, France, 30420
- François LE HINGRAT
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Castelnau Le Lez, France, 34170
- Bernadette CHAUFFAILLE
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Castelnaudary, France, 11400
- Georges BINET
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Castelnaudary, France, 11400
- Hervé VILAREM
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Clarensac, France, 30870
- Gladys HAVARD
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Clarensac, France, 30870
- Marc GARCIA
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Codognan, France, 30920
- Michel AMOUYAL
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Codognan, France, 30920
- Nicole FERRIER
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Colombelles, France, 14460
- Philippe GRUJARD
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Cournonsec, France, 34660
- Philippe HEUZE
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Cournonterrac, France, 34660
- Gregoire MARTOCQ
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Coursan, France, 11110
- Bruno DAUBIN
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Damville, France, 27240
- Jean-Baptiste DE LEMOS
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Dessenheim, France, 68600
- Marcel RUETSCH
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Equeurdreville Hainneville, France, 50120
- Christian DAUGENET
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Evreux, France, 27000
- Gérard DUGNY
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Evreux, France, 27000
- Thierry CANALI
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Fecamp, France, 76400
- Frédéric RENOU
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Fleury Sur Orne, France, 14123
- Pascal MABIRE
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Gambsheim, France, 67760
- Alain LION
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Hangenbieten, France, 67980
- Raymond WESTERFELD
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Hautot Sur Mer, France, 76550
- Gérard TELLIER
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Herlisheim, France, 67850
- Marc BUR
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Ille Sur Tet, France, 66130
- Jean Pascal SASTOURNE
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Laroque Des Alberes, France, 66740
- Reinhard RENNER
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Lasalle, France, 30460
- Christian FLAISSIER
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Lasalle, France, 30460
- Irène LAFONT
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Le Cailar, France, 30740
- Patrick DUTILLEUL
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Lignan Sur Orb, France, 34490
- Claude BRUNAUD
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Lingolsheim, France, 67380
- Jean-Philippe RICHTER
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Marguerittes, France, 30320
- Stéphane BOURGHOL
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Maurin, France, 34970
- Maurice GAY
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Meze, France, 34140
- Patrick OLOMBEL
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Montpellier, France, 30090
- Cécile BELIN-SAUGET
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Montpellier, France, 34000
- Jean François GUILLEM
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Montpellier, France, 34000
- Jean Roch ALEA
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Montpellier, France, 34000
- Marie Pascale DEMOLY
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Montpellier, France, 34000
- MONGIN
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Montpellier, France, 34000
- Thierry AUTARD
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Montpellier, France, 34000
- Victor BASTIDE
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Montpellier, France, 34070
- Michel CHASSAGNE
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Montpellier, France, 34070
- Philippe CAYRON
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Montpellier, France, 34080
- Jean Pierre CANO
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Mulhouse, France, 68200
- Patrick VOGT
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Mundolsheim, France, 67450
- Jean-Louis WURTZ
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Nimes, France, 30000
- Nasser GOUCHENE
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Nimes, France, 30000
- Paul REGNIER-VIGOUROUX
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Nimes, France, 30900
- Claude BERNAT
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Nimes, France, 30900
- Dominique BLOT
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Nimes, France, 30900
- Marie Christine BONS-GALLET
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Nimes, France, 30900
- Philippe IMBERT
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Nîmes, France, 30920
- COSTA
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Obernai, France, 67210
- Georgios MARKIDIS
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Obernai, France, 67210
- Natacha HEITZ
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Obernai, France, 67210
- Yves-Olivier SCHLECHT
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Ottrott, France, 67530
- Guy BIRRY
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Pacy Sur Eure, France, 27120
- Bernard PRIJAC
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Perpignan, France, 66000
- Alain GUERRI
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Perpignan, France, 66000
- Chantal MALZAC
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Perpignan, France, 66000
- Gérard BOURREL
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Pompignan, France, 30170
- Serge ELIE
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Pont Saint Esprit, France, 30130
- Bernard GABBAI
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Pont de L'arche, France, 27340
- Sonia COURTOIS
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Rivesaltes, France, 66600
- Geneviève DURANT
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Rouen, France, 76000
- Baudoin PINSON
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Rouen, France, 76000
- Olivier BAISSAS
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Rousson, France, 30340
- Dominique GENOUD
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Rousson, France, 30340
- Sylvie OLLIVIER
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Rugles, France, 27250
- Patrick VERDAVOINE
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Saint Genis Des Fontaines, France, 66740
- Catherine MERCEY
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Saint Genis Des Fontaines, France, 66740
- Yves MERCEY
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Saint Georges D'orques, France, 34680
- Béatrice LOGNOS-FOLCO
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Saint Sebastien de Morsent, France, 27180
- Jean-Yves DOERR
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Saint Siffret, France, 30700
- Martine FERRE
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Sainte Anastasie, France, 30190
- Gil MEYRAND
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Salses Le Chateau, France, 66600
- Jean Baptiste THIBERT
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Schilttigheim, France, 67300
- Léa ABOAF
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Schilttigheim, France, 67300
- Monique LESCOUTE
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Schilttigheim, France, 67300
- Raymond ATTUIL
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Sete, France, 34200
- Luc ECHINARD
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Sommieres, France, 30250
- Laurent TENNEZE
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Strasbourg, France, 67000
- Charles LOUSQUI
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Strasbourg, France, 67000
- Claire PFRUNNER-SCHNEIDER
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Strasbourg, France, 67000
- Claire ROLLAND-JACQUEMIN
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Strasbourg, France, 67000
- Hélène STURCHLER
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Strasbourg, France, 67000
- Joël ETIENNEZ
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Strasbourg, France, 67000
- Judah TOLEDANO
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Strasbourg, France, 67000
- Nathan ABENHAIM
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Strasbourg, France, 67000
- Patrick KORMANN
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Strasbourg, France, 67000
- Philippe MARMOR
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Strasbourg, France, 67000
- Roland BENEDIC
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Strasbourg, France, 67000
- Véronique PEREZ
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Strasbourg, France, 67100
- Maxime BOUMANDIL
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Tilly Sur Seulles, France, 14250
- Hervé MOREL
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Trebes, France, 11800
- Bernard CLARY
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Trebes, France, 11800
- Jacques GRAVES
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Uchaud, France, 30620
- Christian GIRARD
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Uchaud, France, 30620
- Eric LIOTARD
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Uzes, France, 30700
- Olivier CHAIX
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Valleraugue, France, 30570
- François BAYLE
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Ville, France, 67220
- Philippe BOISSON
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Description:
|
Placebo Comparator: Comparative product : placebo
Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table .
|
Description: - capsule size 3 Composition of the product:
Composition of the capsule:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary criterion is the RQLQ global score measured at the end of Week 0 and Week 5.
Time Frame: Week 0 and Week 5
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Week 0-Week 5
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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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Week 5- Week 7
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jean BOUSQUET, Pr
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13609
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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