Probiotic Administration and Perennial Allergic Rhinitis

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779895
• Other study ID #: 12.18.MET
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: April 8, 2014
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Dietary Supplement:
• Lactobacillus paracasei probiotic strain

• Placebo
maltodextrin

Locations

Country	Name	City	State
Switzerland	Metabolic Unit, Nestlé Research Centre	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)	Compared over 8 weeks between the two treatment groups	8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score		Measured weekly for the 8 weeks of product intake	No
Secondary	Level of Specific Immunoglobulin E		Measured 2 times: at the start of product intake and after 8 weeks	No
Secondary	Frequency of adverse events		during the 8 weeks of product intake	Yes