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Completed

NCT Number: NCT01779895

Probiotic Administration and Perennial Allergic Rhinitis

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.

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Unit, Nestlé Research Centre

Lausanne, 1000, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lactobacillus paracasei probiotic strain

Dietary Supplement

Placebo

Dietary Supplement

maltodextrin

Primary outcomes

  1. Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)

    Time frame: 8 weeks

    Compared over 8 weeks between the two treatment groups

Secondary outcomes

  1. Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells

    Time frame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks

  2. Basophil activation in ex-vivo stimulated whole blood cells

    Time frame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks

  3. Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score

    Time frame: Measured weekly for the 8 weeks of product intake

  4. Level of Specific Immunoglobulin E

    Time frame: Measured 2 times: at the start of product intake and after 8 weeks

  5. Frequency of adverse events

    Time frame: during the 8 weeks of product intake

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
Apr 9, 2014

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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