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

Rijnstate Hospital

Status: Completed

Conditions: Birch Pollen Allergy; Hay Fever

Treatments: Dietary Supplement: Yoghurt; Dietary Supplement: Yoghurt with L.casei; Dietary Supplement: Yoghurt with L. plantarum strain

Study type: Interventional

Funder types: Other

Identifiers

NCT01137357

LTC 559-240908

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 6 patient groups, including a placebo group

Yoghurt with Lactobacillus strain (L.plantarum WCFS1)

Experimental group

Treatment:

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)

Experimental group

Treatment:

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)

Experimental group

Treatment:

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus strain (L.plantarum CBS125632)

Experimental group

Treatment:

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Dietary Supplement: Yoghurt with L. plantarum strain

Yoghurt with Lactobacillus casei Shirota

Active Comparator group

Treatment:

Dietary Supplement: Yoghurt with L.casei

Placebo Yoghurt

Placebo Comparator group

Treatment:

Dietary Supplement: Yoghurt