Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-06

Brief Summary

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With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). In addition, the investigators aim to study the influence of this probiotic chewable on the microbiome of the upper respiratory tract after administration in adults with AR. The bacterial and cytokine profiles in the naso- and oropharynx will be monitored before, during and after the treatment.

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Detailed Description

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Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind, randomized, placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic group

daily use of a probiotic chewable for 8 weeks

Group Type ACTIVE_COMPARATOR

Probiotic chewables

Intervention Type BIOLOGICAL

chewables containing Lacticaseibacillus rhamnosus GG

Placebo group

daily use of the placebo chewable for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo chewables

Intervention Type BIOLOGICAL

chewables without probiotic strain. Ingredients: Xylitol, microcrystalline cellulose, stearic acid, natural orange flavor, silica, magnesium stearate, citric acid and malic acid.

Interventions

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Probiotic chewables

chewables containing Lacticaseibacillus rhamnosus GG

Intervention Type BIOLOGICAL

Placebo chewables

chewables without probiotic strain. Ingredients: Xylitol, microcrystalline cellulose, stearic acid, natural orange flavor, silica, magnesium stearate, citric acid and malic acid.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 at the time of registration;
* Seasonal allergic rhinoconjunctivitis (AR) in the context of grass pollen allergy diagnosed on the basis of anamnesis cfr. ARIA guidelines and positive skin prick test and / or immunocap assay;
* Positive skin prick test (SPT) for grass pollen and / or the presence of specific IgE for grass pollen, confirmed by a medical specialist, measured at the start of the study: Soluprick SQ Phleum pratense pollen 10 HEP - ALK and / or IgE specific immunocap assay Phleum pratense (timothy grass) (g6);
* Body Mass Index in the range of 19-32 kg / m2;
* Instructed during screening and agreed not to use other probiotic products outside of the study during the study period;
* Signed the consent form.

Exclusion Criteria

* Antibiotic use at baseline and during the study;
* Pregnant women;
* Unstable / uncontrolled asthma (to be determined by investigator-physician);
* Sensitization to dust mites
* History of probiotic use in the past two weeks;
* Current diagnosis of cancer or immunosuppressive therapy within the past 6 months;
* Abnormalities of the oral mucosa;
* Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis cfr. EPOS guidelines);
* Clinically significant bleeding disorder;
* Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial;
* History of regular use (\> 3 days out of 7) of tobacco products within the previous two weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No