Completed

Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Maltodextrin

+ Probiotic

Dietary Supplement
Who is being recruted

Hypersensitivity+7

+ Hypersensitivity, Immediate

+ Immune System Diseases

From 20 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: July 12, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

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

NCT01660698
Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: July 12, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, AllergicRhinitis, Allergic, Seasonal

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
maltodextrin powder

Group II

Active Comparator
probiotic blended in maltodextrin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Metabolic Unit, Nestlé Research Center

Lausanne, SwitzerlandOpen Metabolic Unit, Nestlé Research Center in Google Maps
CompletedOne Study Center