Probiotics for Reduction Of Markers In Subjects With Allergy (PROMISA)
Primary Purpose
Hay Fever, Birch Pollen Allergy
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Yoghurt with L. plantarum strain
Yoghurt with L.casei
Yoghurt with L. plantarum strain
Yoghurt with L. plantarum strain
Yoghurt with L. plantarum strain
Yoghurt
Sponsored by
About this trial
This is an interventional treatment trial for Hay Fever
Eligibility Criteria
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
Sites / Locations
- Allergologiepraktijk Arnhem/Radboud/Rijnstate
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Yoghurt with Lactobacillus strain (L.plantarum WCFS1)
Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)
Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)
Yoghurt with Lactobacillus strain (L.plantarum CBS125632)
Yoghurt with Lactobacillus casei Shirota
Placebo Yoghurt
Arm Description
Outcomes
Primary Outcome Measures
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)
Secondary Outcome Measures
Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood
Full Information
NCT ID
NCT01137357
First Posted
June 3, 2010
Last Updated
June 3, 2010
Sponsor
Rijnstate Hospital
Collaborators
Allergologiepraktijk Arnhem/Radboud/Rijnstate, NIZO Food Research, Wageningen University, Campina Innovation
1. Study Identification
Unique Protocol Identification Number
NCT01137357
Brief Title
Probiotics for Reduction Of Markers In Subjects With Allergy
Acronym
PROMISA
Official Title
Probiotics for Reduction Of Markers In Subjects With Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rijnstate Hospital
Collaborators
Allergologiepraktijk Arnhem/Radboud/Rijnstate, NIZO Food Research, Wageningen University, Campina Innovation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hay Fever, Birch Pollen Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoghurt with Lactobacillus strain (L.plantarum WCFS1)
Arm Type
Experimental
Arm Title
Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)
Arm Type
Experimental
Arm Title
Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)
Arm Type
Experimental
Arm Title
Yoghurt with Lactobacillus strain (L.plantarum CBS125632)
Arm Type
Experimental
Arm Title
Yoghurt with Lactobacillus casei Shirota
Arm Type
Active Comparator
Arm Title
Placebo Yoghurt
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Yoghurt with L. plantarum strain
Intervention Description
Intake of yoghurt during 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Yoghurt with L.casei
Intervention Description
Intake of yoghurt during 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Yoghurt with L. plantarum strain
Intervention Description
Intake of yoghurt during 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Yoghurt with L. plantarum strain
Intervention Description
Yoghurt with L. plantarum strain
Intervention Type
Dietary Supplement
Intervention Name(s)
Yoghurt with L. plantarum strain
Intervention Description
Intake of yoghurt during 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Yoghurt
Intervention Description
Intake of yoghurt during 4 weeks
Primary Outcome Measure Information:
Title
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)
Secondary Outcome Measure Information:
Title
Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Jansen, Drs
Organizational Affiliation
Allergologiepraktijk Arnhem/Radboud/Rijnstate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergologiepraktijk Arnhem/Radboud/Rijnstate
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6824 BJ
Country
Netherlands
12. IPD Sharing Statement
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Probiotics for Reduction Of Markers In Subjects With Allergy
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