Probiotics for Reduction Of Markers In Subjects With Allergy
NCT01137357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2010-06-04
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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