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OpenTrials
Completed

NCT Number: NCT01137357

Probiotics for Reduction Of Markers In Subjects With Allergy

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allergologiepraktijk Arnhem/Radboud/Rijnstate

Arnhem, Gelderland, 6824 BJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoghurt with L. plantarum strain

Dietary Supplement

Intake of yoghurt during 4 weeks

Yoghurt with L.casei

Dietary Supplement

Intake of yoghurt during 4 weeks

Yoghurt

Dietary Supplement

Intake of yoghurt during 4 weeks

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

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Allergologiepraktijk Arnhem/Radboud/Rijnstate
  • Campina Innovation
  • NIZO Food Research
  • Wageningen University

Registry information

Acronym: PROMISA

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2010
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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