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Completed

NCT Number: NCT01653652

Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Research Organisation GmbH

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Maltodextrin

Dietary Supplement

Primary outcomes

  1. Total nasal symptom score (TNSS)

    Time frame: every day over 8 weeks

    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.

Secondary outcomes

  1. Total ocular symptom score (TOSS)

    Time frame: every day over 8 weeks

  2. miniRQLQ

    Time frame: every week for 8 weeks

    Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly

  3. Individual nasal and ocular symptoms scores

    Time frame: every day over 8 weeks

  4. Well being index

    Time frame: every week over 8 weeks

  5. Medication Score

    Time frame: every week over 8 weeks

  6. Specific IgE

    Time frame: Baseline and end of study

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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