Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653652
• Other study ID #: 11.31. NRC
• Status: Completed
• Phase: N/A
• First received: July 27, 2012
• Last updated: November 19, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.

Description:

Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults aged 18 to 65 years of age at the time of enrolment.

• Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years)

• Positive Skin Prick Test (SPT)to Grass Pollen (GP).

• Presence of specific IgE to Grass Pollen (GP)

• Have a Body Mass Index in the range 19-32 kg/m2

• Have signed the consent form

• Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period

Exclusion Criteria:

• Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment

• Pregnancy

• Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).

• Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)

• Subjects diagnosed with asthma

• Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months

• Subjects on chronic use of systemic corticosteroids prior to randomization

Study Design

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Dietary Supplement:
• Probiotic

• Maltodextrin

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total nasal symptom score (TNSS)	Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups.	every day over 8 weeks	No
Secondary	Total ocular symptom score (TOSS)		every day over 8 weeks	No
Secondary	miniRQLQ	Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly	every week for 8 weeks	No
Secondary	Individual nasal and ocular symptoms scores		every day over 8 weeks	No
Secondary	Well being index		every week over 8 weeks	No
Secondary	Medication Score		every week over 8 weeks	No
Secondary	Specific IgE		Baseline and end of study	No