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Trial record 16 of 103 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.
 
ClinicalTrials.gov Identifier: NCT01779895
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01779895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
  • 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 ]
  • 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 ]
  • Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score [ Time Frame: Measured weekly for the 8 weeks of product intake ]
  • Level of Specific Immunoglobulin E [ Time Frame: Measured 2 times: at the start of product intake and after 8 weeks ]
  • Frequency of adverse events [ Time Frame: during the 8 weeks of product intake ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotic Administration and Perennial Allergic Rhinitis
Official Title  ICMJE Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Perennial
Intervention  ICMJE
  • Dietary Supplement: Lactobacillus paracasei probiotic strain
  • Dietary Supplement: Placebo
    maltodextrin
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 28, 2013)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779895
Other Study ID Numbers  ICMJE 12.18.MET
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maurice Beaumont, MD Nestlé Research Centre
PRS Account Nestlé
Verification Date April 2014

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