Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

NCT01653652 | Completed DMC

• 1 other identifier: 11.31. NRC
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seasonal Allergic Rhinitis

Keywords

grass pollen; allergic rhinitis; TNSS; miniRQLQ

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Total ocular symptom score (TOSS)

  every day over 8 weeks

• miniRQLQ

  every week for 8 weeks

• Individual nasal and ocular symptoms scores

  every day over 8 weeks

• Well being index

  every week over 8 weeks

• Medication Score

  every week over 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

maltodextrin powder to be taken daily

Dietary Supplement: Maltodextrin

Probiotic

ACTIVE COMPARATOR

Probiotic blended in maltodextrin powder to be taken daily

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic

Maltodextrin DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Charité Research Organisation GmbH

Berlin, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

DE (1)