Probiotics for Reduction Of Markers In Subjects With Allergy

Hay Fever Clinical Trial

— PROMISA  

Official title:

Probiotics for Reduction Of Markers In Subjects With Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137357
• Other study ID #: LTC 559-240908
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: June 3, 2010
• Start date: November 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2010
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Birch Pollen Allergy
• Hay Fever
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

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

Locations

Country	Name	City	State
Netherlands	Allergologiepraktijk Arnhem/Radboud/Rijnstate	Arnhem	Gelderland

Sponsors (5)

Lead Sponsor	Collaborator
Rijnstate Hospital	Allergologiepraktijk Arnhem/Radboud/Rijnstate, Campina Innovation, NIZO Food Research, Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)			No
Secondary	Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood