Probiotics for Reduction Of Markers In Subjects With Allergy (PROMISA)

This study has been completed.

Sponsor:

Collaborators:

Allergologiepraktijk Arnhem/Radboud/Rijnstate

NIZO Food Research

Wageningen University

Campina Innovation

Information provided by:

Rijnstate Hospital

ClinicalTrials.gov Identifier:

NCT01137357

First received: June 3, 2010

Last updated: NA

Last verified: June 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 3, 2010

Last Updated Date

June 3, 2010

Start Date ^ICMJE

November 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Probiotics for Reduction Of Markers In Subjects With Allergy

Official Title ^ICMJE

Probiotics for Reduction Of Markers In Subjects With Allergy

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hay Fever
Birch Pollen Allergy

Intervention ^ICMJE

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
Yoghurt with L. plantarum strain
Dietary Supplement: Yoghurt
Intake of yoghurt during 4 weeks

Study Arm (s)

Experimental: Yoghurt with Lactobacillus strain (L.plantarum WCFS1)
Intervention: Dietary Supplement: Yoghurt with L. plantarum strain
Experimental: Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)
Intervention: Dietary Supplement: Yoghurt with L. plantarum strain
Experimental: Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)
Intervention: Dietary Supplement: Yoghurt with L. plantarum strain
Experimental: Yoghurt with Lactobacillus strain (L.plantarum CBS125632)
Intervention: Dietary Supplement: Yoghurt with L. plantarum strain
Active Comparator: Yoghurt with Lactobacillus casei Shirota
Intervention: Dietary Supplement: Yoghurt with L.casei
Placebo Comparator: Placebo Yoghurt
Intervention: Dietary Supplement: Yoghurt

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01137357

Other Study ID Numbers ^ICMJE

LTC 559-240908

Has Data Monitoring Committee

Responsible Party

Drs. A. Jansen, Allergologiepraktijk Arnhem/Radboud/Rijnstate

Study Sponsor ^ICMJE

Rijnstate Hospital

Collaborators ^ICMJE

Allergologiepraktijk Arnhem/Radboud/Rijnstate
NIZO Food Research
Wageningen University
Campina Innovation

Investigators ^ICMJE

Principal Investigator:

A Jansen, Drs

Allergologiepraktijk Arnhem/Radboud/Rijnstate

Information Provided By

Rijnstate Hospital

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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