Probiotics for Reduction Of Markers In Subjects With Allergy

Not Applicable

Completed

• Conditions: Hay Fever; Birch Pollen Allergy
• Interventions: Dietary Supplement: Yoghurt with L. plantarum strain; Dietary Supplement: Yoghurt with L.casei; Dietary Supplement: Yoghurt

• Registration Number: NCT01137357
• Lead Sponsor: Rijnstate Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Last Update Submitted: 2010-06-03
• Study First Posted: 2010-06-04
• Last Update Posted: 2010-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• birch pollen sensitive subjects
• Positive RAST or intracutane skintest
• age 18-50
• signed informed consent form

Exclusion Criteria

• use of probiotics
• known allergy for pets (home setting)
• use of medication influencing the immune system
• use of antibiotics
• lactose intolerance
• pregnancy
• infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoghurt with Lactobacillus strain (L.plantarum WCFS1)	Yoghurt with L. plantarum strain	-
Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)	Yoghurt with L. plantarum strain	-
Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)	Yoghurt with L. plantarum strain	-
Yoghurt with Lactobacillus strain (L.plantarum CBS125632)	Yoghurt with L. plantarum strain	-
Yoghurt with Lactobacillus casei Shirota	Yoghurt with L.casei	-
Placebo Yoghurt	Yoghurt	-

Primary Outcome Measures

Name	Time	Method
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)

Secondary Outcome Measures

Name	Time	Method
Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood

Trial Locations

Locations (1)

Allergologiepraktijk Arnhem/Radboud/Rijnstate; 🇳🇱 Arnhem, Gelderland, Netherlands