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

June 3, 2010 updated by: Rijnstate Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6824 BJ
        • Allergologiepraktijk Arnhem/Radboud/Rijnstate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoghurt with Lactobacillus strain (L.plantarum WCFS1)
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
Experimental: Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)
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
Experimental: Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)
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
Experimental: Yoghurt with Lactobacillus strain (L.plantarum CBS125632)
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
Active Comparator: Yoghurt with Lactobacillus casei Shirota
Dietary supplement: Yoghurt with L.casei
Intake of yoghurt during 4 weeks
Placebo Comparator: Placebo Yoghurt
Dietary supplement: Yoghurt
Intake of yoghurt during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

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

Investigators

  • Principal Investigator: A Jansen, Drs, Allergologiepraktijk Arnhem/Radboud/Rijnstate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimate)

June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

June 4, 2010

Last Update Submitted That Met QC Criteria

June 3, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC 559-240908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hay Fever

Clinical Trials on Yoghurt with L. plantarum strain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe