Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

NCT04898686 | Completed

• 1 other identifier: B3002020000086
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lactobacilli; microbiome; probiotic chewables

Outcome Measures

Primary Outcomes (2)

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

  qPCR

  at 8 weeks

• Changes in the score of allergic rhinitis symptoms

  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.

  over the study period (= 10 weeks)

Secondary Outcomes (5)

• changes in microbiome of the oronasopharyngeal region after administration of the chewable

  baseline, 8 weeks

• Inlfuence on general nose- and mouth health

  baseline, 8 weeks, 10 weeks

• Changes in the absolute numbers of specific airway pathogens and viruses

  baseline, 8 weeks

• 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

  baseline, 8 weeks

• Frequency of medication use

  over the study period (= 10 weeks)

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

daily use of a probiotic chewable for 8 weeks

Biological: Probiotic chewables

Placebo group

PLACEBO COMPARATOR

daily use of the placebo chewable for 8 weeks

Biological: Placebo chewables

Interventions

Probiotic chewables BIOLOGICAL

chewables containing Lacticaseibacillus rhamnosus GG

Probiotic group

Placebo chewables BIOLOGICAL

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of regular use (\> 3 days out of 7) of tobacco products within the previous two weeks

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Belgium

Location

Study Officials

• Sarah Lebeer, Prof

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Olivier Vanderveken, Prof

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.ir.

Model Details: double blind, randomized, placebo controlled

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 24, 2021
• Study Start: August 1, 2020
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

BE (1)