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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
  Purpose

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 Intervention
Rhinitis, Allergic, Perennial
Dietary Supplement: Lactobacillus paracasei probiotic strain
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NCC2461
probiotic blended in maltodextrin powder to be taken daily
Dietary Supplement: Lactobacillus paracasei probiotic strain
Placebo Comparator: Placebo
maltodextrin
Dietary Supplement: Placebo
maltodextrin

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779895

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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01779895     History of Changes
Other Study ID Numbers: 12.18.MET
Study First Received: January 22, 2013
Last Updated: April 8, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Nestlé:
Dust mite
Perennial allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 24, 2014