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Probiotic Administration and Perennial Allergic Rhinitis

N

Nestlé

Status

Completed

Conditions

Rhinitis, Allergic, Perennial

Treatments

Dietary Supplement: Lactobacillus paracasei probiotic strain
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01779895
12.18.MET

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

64 participants in 2 patient groups, including a placebo group

NCC2461
Active Comparator group
Description:
probiotic blended in maltodextrin powder to be taken daily
Treatment:
Dietary Supplement: Lactobacillus paracasei probiotic strain
Placebo
Placebo Comparator group
Description:
maltodextrin
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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