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

This study has been completed.
Sponsor:
Collaborator:
Chr Hansen A/S
Information provided by (Responsible Party):
Merck Medication Familiale
ClinicalTrials.gov Identifier:
NCT01096615
First received: March 30, 2010
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Rhinitis
Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus paracasei LP-33
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Medication Familiale:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: 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.
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 .
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.


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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096615

  Show 125 Study Locations
Sponsors and Collaborators
Merck Medication Familiale
Chr Hansen A/S
Investigators
Study Chair: Jean BOUSQUET, Pr
  More Information

No publications provided

Responsible Party: Merck Medication Familiale
ClinicalTrials.gov Identifier: NCT01096615     History of Changes
Other Study ID Numbers: 13609
Study First Received: March 30, 2010
Last Updated: July 25, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Merck Medication Familiale:
Allergic rhinitis-Probiotic Lactobacillus paracasei LP-33-

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 20, 2014