Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens

Rhinitis Clinical Trial

— BionAtlanta  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096615
• Other study ID #: 13609
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2010
• Last updated: July 25, 2012
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Merck Medication Familiale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rhinitis

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
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	Jean DEFLAUX	Beaucaire
France	Sébastien CONVENT	Beauvoisin
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	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	Equeurdreville Hainneville
France	Gérard DUGNY	Evreux
France	Thierry CANALI	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	Reinhard RENNER	Laroque Des Alberes
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	Meze
France	Cécile BELIN-SAUGET	Montpellier
France	Jean François GUILLEM	Montpellier
France	Jean Pierre CANO	Montpellier
France	Jean Roch ALEA	Montpellier
France	Marie Pascale DEMOLY	Montpellier
France	Michel CHASSAGNE	Montpellier
France	MONGIN	Montpellier
France	Philippe CAYRON	Montpellier
France	Thierry AUTARD	Montpellier
France	Victor BASTIDE	Montpellier
France	Patrick VOGT	Mulhouse
France	Jean-Louis WURTZ	Mundolsheim
France	Claude BERNAT	Nimes
France	Dominique BLOT	Nimes
France	Marie Christine BONS-GALLET	Nimes
France	Nasser GOUCHENE	Nimes
France	Paul REGNIER-VIGOUROUX	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	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	Catherine MERCEY	Saint Genis Des Fontaines
France	Yves MERCEY	Saint Genis Des Fontaines
France	Béatrice LOGNOS-FOLCO	Saint Georges D'orques
France	Jean-Yves DOERR	Saint Sebastien de Morsent
France	Martine FERRE	Saint Siffret
France	Gil MEYRAND	Sainte Anastasie
France	Jean Baptiste THIBERT	Salses Le Chateau
France	Léa ABOAF	Schilttigheim
France	Monique LESCOUTE	Schilttigheim
France	Raymond ATTUIL	Schilttigheim
France	Luc ECHINARD	Sete
France	Laurent TENNEZE	Sommieres
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	Maxime BOUMANDIL	Strasbourg
France	Nathan ABENHAIM	Strasbourg
France	Patrick KORMANN	Strasbourg
France	Philippe MARMOR	Strasbourg
France	Roland BENEDIC	Strasbourg
France	Véronique PEREZ	Strasbourg
France	Hervé MOREL	Tilly Sur Seulles
France	Bernard CLARY	Trebes
France	Jacques GRAVES	Trebes
France	Christian GIRARD	Uchaud
France	Eric LIOTARD	Uchaud
France	Olivier CHAIX	Uzes
France	François BAYLE	Valleraugue
France	Philippe BOISSON	Ville

Sponsors (2)

Lead Sponsor	Collaborator
Merck Medication Familiale	Chr Hansen A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To show an increase in the time of 1st exacerbation of symptoms of rhinitis symptom with Lactobacillus paracasei LP-33		Week 5- Week 7	No