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Trial record 16 of 99 for:    Lactobacillus | maltodextrin

Probiotic Administration and Perennial Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779895
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : April 9, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Dietary Supplement: Lactobacillus paracasei probiotic strain Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
Study Start Date : December 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: NCC2461
probiotic blended in maltodextrin powder to be taken daily
Dietary Supplement: Lactobacillus paracasei probiotic strain
Placebo Comparator: Placebo
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) [ Time Frame: 8 weeks ]
    Compared over 8 weeks between the two treatment groups

Secondary Outcome Measures :
  1. Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells [ Time Frame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks ]
  2. Basophil activation in ex-vivo stimulated whole blood cells [ Time Frame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks ]
  3. Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score [ Time Frame: Measured weekly for the 8 weeks of product intake ]
  4. Level of Specific Immunoglobulin E [ Time Frame: Measured 2 times: at the start of product intake and after 8 weeks ]
  5. Frequency of adverse events [ Time Frame: during the 8 weeks of product intake ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults between 20-65 years old
  • Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
  • Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
  • Body Mass Index 19-29
  • Having obtained his/her informed consent

Exclusion Criteria:

  • Anemia
  • Allergy to any food or medication
  • Asthma
  • Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
  • Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
  • Consumption of probiotic and other dietary nutritional interventions
  • More than 2 drinks/day alcohol consumption or use of illicit drugs
  • Pregnant women
  • Subjects with expected low compliance
  • Blood donation in the past month or planning to donate blood until a month after the end of the study
  • Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779895

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Metabolic Unit, Nestlé Research Centre
Lausanne, Switzerland, 1000
Sponsors and Collaborators
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Principal Investigator: Maurice Beaumont, MD Nestlé Research Centre

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Responsible Party: Nestlé Identifier: NCT01779895     History of Changes
Other Study ID Numbers: 12.18.MET
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Nestlé:
Dust mite
Perennial allergic rhinitis
Additional relevant MeSH terms:
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Rhinitis, Allergic, Perennial
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases