Skip to main content
OpenTrials
Completed

NCT Number: NCT04898686

Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Probiotic chewables

Biological

chewables containing Lacticaseibacillus rhamnosus GG

Placebo chewables

Biological

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

Primary outcomes

  1. Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable

    Time frame: at 8 weeks

    qPCR

  2. Changes in the score of allergic rhinitis symptoms

    Time frame: over the study period (= 10 weeks)

    Daily questionnaires will be used, in which a self-reported Total Nasal Symptom Score (TNSS) based on rhinorrhea, nasal congestion, nasal itching and sneezing with symptom severity ranging from 0 (no problem) to 12 (very severe problem) will be recorded.

Secondary outcomes

  1. changes in microbiome of the oronasopharyngeal region after administration of the chewable

    Time frame: baseline, 8 weeks

    16S rRNA amplicon sequencing

  2. Inlfuence on general nose- and mouth health

    Time frame: baseline, 8 weeks, 10 weeks

    A clinical evaluation by an ENT specialist will be performed at the start and 8 weeks of the study to assess the general nose and mouth health of the participants. Questions on discomfort and symptoms of inflammation or infection in the nose and mouth will be included in the Sino-Nasal Outcome Test (SNOT-22)-based questionnaire implemented at the start, week 8 and week 10. Symptoms will be scored from 0 (no problem) to 5 (very severe problem)

  3. Changes in the absolute numbers of specific airway pathogens and viruses

    Time frame: baseline, 8 weeks

    qPCR

  4. Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in oro- and nasopharynx samples, and cytokine and antibody levels in blood samples

    Time frame: baseline, 8 weeks

    qPCR and/or ELISA

  5. Frequency of medication use

    Time frame: over the study period (= 10 weeks)

    Daily questionnaires will be used where the type and frequency of medication use should be recorded

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

Study of the Probiotic Potential of a Lacticaseibacillus Strain in the Upper Airways in Patients With Allergic Rhinoconjunctivitis After Administration in a Chewable

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 24, 2021
Registry last updated
Apr 15, 2022

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.

Published trials that share one or more normalized conditions with this study.