Probiotic Administration and Perennial Allergic Rhinitis

April 8, 2014 updated by: Nestlé

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1000
        • Metabolic Unit, Nestlé Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
maltodextrin
Dietary supplement: Placebo
maltodextrin
Active Comparator: NCC2461
probiotic blended in maltodextrin powder to be taken daily
Dietary supplement: Lactobacillus paracasei probiotic strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
during the 8 weeks of product intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Maurice Beaumont, MD, Nestlé Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.18.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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