Probiotic Administration and Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01779895
First received: January 22, 2013
Last updated: April 8, 2014
Last verified: April 2014

January 22, 2013
April 8, 2014
December 2012
January 2013   (final data collection date for primary outcome measure)
Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Compared over 8 weeks between the two treatment groups
Same as current
Complete list of historical versions of study NCT01779895 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score [ Time Frame: Measured weekly for the 8 weeks of product intake ] [ Designated as safety issue: No ]
  • Level of Specific Immunoglobulin E [ Time Frame: Measured 2 times: at the start of product intake and after 8 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: during the 8 weeks of product intake ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Probiotic Administration and Perennial Allergic Rhinitis
Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
  • Dietary Supplement: Lactobacillus paracasei probiotic strain
  • Dietary Supplement: Placebo
    maltodextrin
  • Active Comparator: NCC2461
    probiotic blended in maltodextrin powder to be taken daily
    Intervention: Dietary Supplement: Lactobacillus paracasei probiotic strain
  • Placebo Comparator: Placebo
    maltodextrin
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01779895
12.18.MET
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Maurice Beaumont, MD Nestlé Research Centre
Nestlé
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP