NCT01137357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
Last Updated

June 4, 2010

Status Verified

June 1, 2010

Enrollment Period

1 month

First QC Date

June 3, 2010

Last Update Submit

June 3, 2010

Conditions

Hay FeverBirch Pollen Allergy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (6)

Yoghurt with Lactobacillus strain (L.plantarum WCFS1)

EXPERIMENTAL
Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)

EXPERIMENTAL
Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)

EXPERIMENTAL
Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus strain (L.plantarum CBS125632)

EXPERIMENTAL
Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus casei Shirota

ACTIVE COMPARATOR
Dietary Supplement: Yoghurt with L.casei

Placebo Yoghurt

PLACEBO COMPARATOR
Dietary Supplement: Yoghurt

Interventions

Yoghurt with L. plantarum strainDIETARY_SUPPLEMENT

Intake of yoghurt during 4 weeks

Yoghurt with Lactobacillus strain (L.plantarum WCFS1)
Yoghurt with L.caseiDIETARY_SUPPLEMENT

Intake of yoghurt during 4 weeks

Yoghurt with Lactobacillus casei Shirota
YoghurtDIETARY_SUPPLEMENT

Intake of yoghurt during 4 weeks

Placebo Yoghurt

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • birch pollen sensitive subjects
  • Positive RAST or intracutane skintest
  • age 18-50
  • signed informed consent form

You may not qualify if:

  • use of probiotics
  • known allergy for pets (home setting)
  • use of medication influencing the immune system
  • use of antibiotics
  • lactose intolerance
  • pregnancy
  • infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergologiepraktijk Arnhem/Radboud/Rijnstate

Arnhem, Gelderland, 6824 BJ, Netherlands

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • A Jansen, Drs

    Allergologiepraktijk Arnhem/Radboud/Rijnstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 4, 2010

Study Start

November 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 4, 2010

Record last verified: 2010-06

Locations

NL(1)