search
Back to results

Probiotic Administration and Perennial Allergic Rhinitis

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lactobacillus paracasei probiotic strain
Placebo
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Dust mite, Perennial allergic rhinitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metabolic Unit, Nestlé Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NCC2461

Placebo

Arm Description

probiotic blended in maltodextrin powder to be taken daily

maltodextrin

Outcomes

Primary Outcome Measures

Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
Compared over 8 weeks between the two treatment groups

Secondary Outcome Measures

Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells
Basophil activation in ex-vivo stimulated whole blood cells
Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score
Level of Specific Immunoglobulin E
Frequency of adverse events

Full Information

First Posted
January 22, 2013
Last Updated
April 8, 2014
Sponsor
Société des Produits Nestlé (SPN)
search

1. Study Identification

Unique Protocol Identification Number
NCT01779895
Brief Title
Probiotic Administration and Perennial Allergic Rhinitis
Official Title
Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
Dust mite, Perennial allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NCC2461
Arm Type
Active Comparator
Arm Description
probiotic blended in maltodextrin powder to be taken daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus paracasei probiotic strain
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
maltodextrin
Primary Outcome Measure Information:
Title
Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
Description
Compared over 8 weeks between the two treatment groups
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score
Time Frame
Measured weekly for the 8 weeks of product intake
Title
Level of Specific Immunoglobulin E
Time Frame
Measured 2 times: at the start of product intake and after 8 weeks
Title
Frequency of adverse events
Time Frame
during the 8 weeks of product intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Beaumont, MD
Organizational Affiliation
Nestlé Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metabolic Unit, Nestlé Research Centre
City
Lausanne
ZIP/Postal Code
1000
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Probiotic Administration and Perennial Allergic Rhinitis

We'll reach out to this number within 24 hrs