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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137357
First Posted: June 4, 2010
Last Update Posted: June 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Allergologiepraktijk Arnhem/Radboud/Rijnstate
NIZO Food Research
Wageningen University
Campina Innovation
Information provided by:
Rijnstate Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics for Reduction Of Markers In Subjects With Allergy

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Drs. A. Jansen, Allergologiepraktijk Arnhem/Radboud/Rijnstate
ClinicalTrials.gov Identifier: NCT01137357     History of Changes
Other Study ID Numbers: LTC 559-240908
First Submitted: June 3, 2010
First Posted: June 4, 2010
Last Update Posted: June 4, 2010
Last Verified: June 2010

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