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RhinitisPhase 3BionAtlantaNCT01096615

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

A Phase 3 study testing Lactobacillus paracasei LP-33 in people with Rhinitis, run by Merck Medication Familiale at 125 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Rhinitis
What is being tested?
Lactobacillus paracasei LP-33
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
125 sitesFrance
Study dates
Apr 2010to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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).

Trial locations and contacts

125 sites in 1 country.

125 sites in 1 country

France125 sites

  • Corinne SION

    Aix-en-Provence, 13100

  • Alain FAUDIN

    Alès, 30100

  • Philippe PIAT

    Alès, 30100

  • Sylvie CHABROL-RIVIERE

    Alès, 30100

  • Daniel FERET

    Aubevoye, 27940

  • Florian KOMAC

    Aubord, 30620

  • Alain GIACOMINO

    Avoine, 37420

  • Jean DEFLAUX

    Beaucaire, 30300

  • Sébastien CONVENT

    Beauvoisin, 30640

  • Catherine BRUNET-CAZOT

    Béziers, 34500

  • Emmanuel DEJOUX

    Béziers, 34500

  • Gabriel VENTURINI

    Béziers, 34500

  • Nicolas BRETON

    Béziers, 34500

  • Robert COMBET

    Béziers, 34500

  • Thierry STEFANAGGI

    Béziers, 34500

  • Olivier BISCH

    Bischeim, 67800

  • Sabine GRUTTER

    Bischeim, 67800

  • Sophie ROSENBERG

    Bischeim, 67800

  • Jacques RAMBAUD

    Bompas, 66430

  • Chantal MARTIN

    Bouillargues, 30230

  • Catherine AYRAL

    Boujan-sur-Libron, 34760

  • Laurence DAGES

    Bourg-Achard, 27310

  • Dominique EDET

    Bretteville-l'Orgueilleuse, 14740

  • Didier CADINOT

    Broglie, 27270

  • François LE HINGRAT

    Calvisson, 30420

  • Bernadette CHAUFFAILLE

    Castelnau-le-Lez, 34170

  • Georges BINET

    Castelnaudary, 11400

  • Hervé VILAREM

    Castelnaudary, 11400

  • Gladys HAVARD

    Clarensac, 30870

  • Marc GARCIA

    Clarensac, 30870

  • Michel AMOUYAL

    Codognan, 30920

  • Nicole FERRIER

    Codognan, 30920

  • Philippe GRUJARD

    Colombelles, 14460

  • Philippe HEUZE

    Cournonsec, 34660

  • Gregoire MARTOCQ

    Cournonterrac, 34660

  • Bruno DAUBIN

    Coursan, 11110

  • Jean-Baptiste DE LEMOS

    Damville, 27240

  • Marcel RUETSCH

    Dessenheim, 68600

  • Christian DAUGENET

    Équeurdreville-Hainneville, 50120

  • Gérard DUGNY

    Évreux, 27000

  • Thierry CANALI

    Évreux, 27000

  • Frédéric RENOU

    Fécamp, 76400

  • Pascal MABIRE

    Fleury-sur-Orne, 14123

  • Alain LION

    Gambsheim, 67760

  • Raymond WESTERFELD

    Hangenbieten, 67980

  • Gérard TELLIER

    Hautot-sur-Mer, 76550

  • Marc BUR

    Herlisheim, 67850

  • Jean Pascal SASTOURNE

    Ille-sur-Têt, 66130

  • Reinhard RENNER

    Laroque-des-Albères, 66740

  • Christian FLAISSIER

    Lasalle, 30460

  • Irène LAFONT

    Lasalle, 30460

  • Patrick DUTILLEUL

    Le Cailar, 30740

  • Claude BRUNAUD

    Lignan-sur-Orb, 34490

  • Jean-Philippe RICHTER

    Lingolsheim, 67380

  • Stéphane BOURGHOL

    Marguerittes, 30320

  • Maurice GAY

    Maurin, 34970

  • Patrick OLOMBEL

    Mèze, 34140

  • Cécile BELIN-SAUGET

    Montpellier, 30090

  • Jean François GUILLEM

    Montpellier, 34000

  • Jean Roch ALEA

    Montpellier, 34000

  • Marie Pascale DEMOLY

    Montpellier, 34000

  • MONGIN

    Montpellier, 34000

  • Thierry AUTARD

    Montpellier, 34000

  • Victor BASTIDE

    Montpellier, 34000

  • Michel CHASSAGNE

    Montpellier, 34070

  • Philippe CAYRON

    Montpellier, 34070

  • Jean Pierre CANO

    Montpellier, 34080

  • Patrick VOGT

    Mulhouse, 68200

  • Jean-Louis WURTZ

    Mundolsheim, 67450

  • Nasser GOUCHENE

    Nîmes, 30000

  • Paul REGNIER-VIGOUROUX

    Nîmes, 30000

  • Claude BERNAT

    Nîmes, 30900

  • Dominique BLOT

    Nîmes, 30900

  • Marie Christine BONS-GALLET

    Nîmes, 30900

  • Philippe IMBERT

    Nîmes, 30900

  • COSTA

    Nîmes, 30920

  • Georgios MARKIDIS

    Obernai, 67210

  • Natacha HEITZ

    Obernai, 67210

  • Yves-Olivier SCHLECHT

    Obernai, 67210

  • Guy BIRRY

    Ottrott, 67530

  • Bernard PRIJAC

    Pacy-sur-Eure, 27120

  • Alain GUERRI

    Perpignan, 66000

  • Chantal MALZAC

    Perpignan, 66000

  • Gérard BOURREL

    Perpignan, 66000

  • Serge ELIE

    Pompignan, 30170

  • Sonia COURTOIS

    Pont-de-l'Arche, 27340

  • Bernard GABBAI

    Pont-Saint-Esprit, 30130

  • Geneviève DURANT

    Rivesaltes, 66600

  • Baudoin PINSON

    Rouen, 76000

  • Olivier BAISSAS

    Rouen, 76000

  • Dominique GENOUD

    Rousson, 30340

  • Sylvie OLLIVIER

    Rousson, 30340

  • Patrick VERDAVOINE

    Rugles, 27250

  • Catherine MERCEY

    Saint-Génis-des-Fontaines, 66740

  • Yves MERCEY

    Saint-Génis-des-Fontaines, 66740

  • Béatrice LOGNOS-FOLCO

    Saint-Georges-dOrques, 34680

  • Jean-Yves DOERR

    Saint-Sébastien-de-Morsent, 27180

  • Martine FERRE

    Saint-Siffret, 30700

  • Gil MEYRAND

    Sainte-Anastasie, 30190

  • Jean Baptiste THIBERT

    Salses-le-Château, 66600

  • Léa ABOAF

    Schilttigheim, 67300

  • Monique LESCOUTE

    Schilttigheim, 67300

  • Raymond ATTUIL

    Schilttigheim, 67300

  • Luc ECHINARD

    Sète, 34200

  • Laurent TENNEZE

    Sommières, 30250

  • Charles LOUSQUI

    Strasbourg, 67000

  • Claire PFRUNNER-SCHNEIDER

    Strasbourg, 67000

  • Claire ROLLAND-JACQUEMIN

    Strasbourg, 67000

  • Hélène STURCHLER

    Strasbourg, 67000

  • Joël ETIENNEZ

    Strasbourg, 67000

  • Judah TOLEDANO

    Strasbourg, 67000

  • Nathan ABENHAIM

    Strasbourg, 67000

  • Patrick KORMANN

    Strasbourg, 67000

  • Philippe MARMOR

    Strasbourg, 67000

  • Roland BENEDIC

    Strasbourg, 67000

  • Véronique PEREZ

    Strasbourg, 67000

  • Maxime BOUMANDIL

    Strasbourg, 67100

  • Hervé MOREL

    Tilly-sur-Seulles, 14250

  • Bernard CLARY

    Trèbes, 11800

  • Jacques GRAVES

    Trèbes, 11800

  • Christian GIRARD

    Uchaud, 30620

  • Eric LIOTARD

    Uchaud, 30620

  • Olivier CHAIX

    Uzès, 30700

  • François BAYLE

    Valleraugue, 30570

  • Philippe BOISSON

    Villé, 67220

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Rhinitis
Being tested
Placebo, Lactobacillus paracasei LP-33
Keywords
Allergic rhinitis-Probiotic Lactobacillus paracasei LP-33-
Medical subject headings
Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    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-33Dietary supplement

    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.
Study groups in NCT01096615
Study groupRoleWhat they receive
Tested product: Lactobacillus paracasei LP-33Active comparatorEach patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table
Receives: Dietary Supplement: Lactobacillus paracasei LP-33
Comparative product : placeboPlacebo comparatorEach patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table .
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 0 and Week 5

Secondary outcomes (2)

  1. To show a decrease in allergic rhinitis symptoms on the 5th week of product consumption (as assessed by RQLQ and RTSS-5)

    Measured: Week 0-Week 5

  2. To show an increase in the time of 1st exacerbation of symptoms of rhinitis symptom with Lactobacillus paracasei LP-33

    Measured: Week 5- Week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01096615
Sponsor's protocol ID
13609
Acronym
BionAtlanta
Status last verified
Jul 2012
First submitted
30 Mar 2010
Last updated
26 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lactobacillus paracasei LP-33 in people with Rhinitis, run by Merck Medication Familiale at 125 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01096615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.

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