Clinical Trials Directory

Trials / Completed

CompletedNCT01137357

Probiotics for Reduction Of Markers In Subjects With Allergy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Rijnstate Hospital · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch pollen allergy is one of the most common forms of respiratory allergy in European countries, and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated for their immunomodulatory properties in birch pollen sensitive subjects outside the hay fever season. A double-blind placebo-controlled parallel study will be performed in which subjects with a proven birch pollen allergy will consume one of 5 different probiotic yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood samples are collected at the start and after 4 weeks. Immune parameters are determined in serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTYoghurt with L. plantarum strainIntake of yoghurt during 4 weeks
DIETARY_SUPPLEMENTYoghurt with L.caseiIntake of yoghurt during 4 weeks
DIETARY_SUPPLEMENTYoghurt with L. plantarum strainIntake of yoghurt during 4 weeks
DIETARY_SUPPLEMENTYoghurt with L. plantarum strainYoghurt with L. plantarum strain
DIETARY_SUPPLEMENTYoghurt with L. plantarum strainIntake of yoghurt during 4 weeks
DIETARY_SUPPLEMENTYoghurtIntake of yoghurt during 4 weeks

Timeline

Start date
2008-11-01
Primary completion
2008-12-01
Completion
2008-12-01
First posted
2010-06-04
Last updated
2010-06-04

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01137357. Inclusion in this directory is not an endorsement.