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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
  Purpose

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.


Condition Intervention
Hay Fever
Birch Pollen Allergy
 Dietary Supplement: Yoghurt with L. plantarum strain
Dietary Supplement: Yoghurt with L.casei
Dietary Supplement: Yoghurt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics for Reduction Of Markers In Subjects With Allergy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

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

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

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoghurt with Lactobacillus strain (L.plantarum WCFS1) Dietary Supplement: Yoghurt with L. plantarum strain
Intake of yoghurt during 4 weeks
Experimental: Yoghurt with Lactobacillus strain (L.plantarum NIZO3400) Dietary Supplement: Yoghurt with L. plantarum strain
Intake of yoghurt during 4 weeks
Experimental: Yoghurt with Lactobacillus strain (L. plantarum NIZO2877) Dietary Supplement: Yoghurt with L. plantarum strain
Intake of yoghurt during 4 weeks
Experimental: Yoghurt with Lactobacillus strain (L.plantarum CBS125632) 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137357

Locations
Netherlands
Allergologiepraktijk Arnhem/Radboud/Rijnstate
Arnhem, Gelderland, Netherlands, 6824 BJ
Sponsors and Collaborators
Rijnstate Hospital
Allergologiepraktijk Arnhem/Radboud/Rijnstate
NIZO Food Research
Wageningen University
Campina Innovation
Investigators
Principal Investigator: A Jansen, Drs Allergologiepraktijk Arnhem/Radboud/Rijnstate
  More Information

No publications provided

Responsible Party: Drs. A. Jansen, Allergologiepraktijk Arnhem/Radboud/Rijnstate
ClinicalTrials.gov Identifier: NCT01137357     History of Changes
Other Study ID Numbers: LTC 559-240908
Study First Received: June 3, 2010
Last Updated: June 3, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 16, 2013