Probiotics for Reduction Of Markers In Subjects With Allergy

NCT01137357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-06-04

No results posted yet for this study

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

  • Hay Fever
  • Birch Pollen Allergy

Interventions

DIETARY_SUPPLEMENT

Yoghurt with L. plantarum strain

Intake of yoghurt during 4 weeks

DIETARY_SUPPLEMENT

Yoghurt with L.casei

Intake of yoghurt during 4 weeks

DIETARY_SUPPLEMENT

Yoghurt with L. plantarum strain

Intake of yoghurt during 4 weeks

DIETARY_SUPPLEMENT

Yoghurt with L. plantarum strain

Yoghurt with L. plantarum strain

DIETARY_SUPPLEMENT

Yoghurt with L. plantarum strain

Intake of yoghurt during 4 weeks

DIETARY_SUPPLEMENT

Yoghurt

Intake of yoghurt during 4 weeks

Sponsors & Collaborators

  • Allergologiepraktijk Arnhem/Radboud/Rijnstate

    collaborator UNKNOWN
  • NIZO Food Research

    collaborator OTHER
  • Wageningen University

    collaborator OTHER
  • Campina Innovation

    collaborator UNKNOWN
  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • A Jansen, Drs · Allergologiepraktijk Arnhem/Radboud/Rijnstate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137357 on ClinicalTrials.gov