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Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals

N

Nestlé

Status

Completed

Conditions

Seasonal Allergic Rhinitis

Treatments

Dietary Supplement: Probiotic
Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01660698
11.03.MET

Details and patient eligibility

About

The purpose of the current study is to evaluate the effect of administering a probiotic strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in seasonal allergic rhinitis subjects.

Full description

To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure

Enrollment

20 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed allergy (allergic rhinitis) to grass pollen > 1 year and positive SPT > 3mm wheal diameter to grass pollen.
  • Age 20-65 years adults
  • Body Mass Index 19- 29 (people in the normal and overweight range)
  • Having obtained his/her informed consent.

Exclusion criteria

  • Anemia

  • Family history of congenital immunodeficiency

  • Regular consumption of immunosuppressive or anti-inflammatory treatment

  • Under medication against allergy (e.g. anti histaminic)

  • Avoid regular consumption of probiotic and other dietary nutritional interventions

  • Have a high alcohol consumption (more than 1 drink/day)

  • Consumption of illicit drugs

  • Pregnancy

    • Subject who cannot be expected to comply with the study procedures, including consuming the test products
    • Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
maltodextrin powder
Treatment:
Dietary Supplement: Maltodextrin
Probiotic
Active Comparator group
Description:
probiotic blended in maltodextrin
Treatment:
Dietary Supplement: Probiotic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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