Probiotic Administration and Perennial Allergic Rhinitis

Not Applicable

Completed

• Conditions: Rhinitis, Allergic, Perennial

• Registration Number: NCT01779895
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Study Completion: 2013-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells	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	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	Measured weekly for the 8 weeks of product intake
Level of Specific Immunoglobulin E	Measured 2 times: at the start of product intake and after 8 weeks
Frequency of adverse events	during the 8 weeks of product intake

Trial Locations

Locations (1)

Metabolic Unit, Nestlé Research Centre; 🇨🇭 Lausanne, Switzerland