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Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

NCT04898686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

Probiotic chewables

chewables containing Lacticaseibacillus rhamnosus GG

BIOLOGICAL

Placebo chewables

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

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    collaborator INDUSTRY

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Sarah Lebeer, Prof · Universiteit Antwerpen

  • Olivier Vanderveken, Prof · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-06
Completion
2021-08-06

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898686 on ClinicalTrials.gov