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Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

Primary Purpose

Allergic Rhinoconjunctivitis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Probiotic chewables

Placebo chewables

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring lactobacilli, microbiome, probiotic chewables

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Antwerp University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

daily use of a probiotic chewable for 8 weeks

daily use of the placebo chewable for 8 weeks

Outcomes

Primary Outcome Measures

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

qPCR

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.

Secondary Outcome Measures

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

16S rRNA amplicon sequencing

Inlfuence on general nose- and mouth health

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)

Changes in the absolute numbers of specific airway pathogens and viruses

qPCR

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

qPCR and/or ELISA

Frequency of medication use

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

Full Information

NCT ID

NCT04898686

First Posted

April 28, 2021

Last Updated

April 7, 2022

Sponsor

University Hospital, Antwerp

Collaborators

DSM Nutritional Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04898686

Brief Title

Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

August 6, 2021 (Actual)

Study Completion Date

August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Antwerp

Collaborators

DSM Nutritional Products, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinoconjunctivitis

Keywords

lactobacilli, microbiome, probiotic chewables

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

double blind, randomized, placebo controlled

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic group

Arm Type

Active Comparator

Arm Description

daily use of a probiotic chewable for 8 weeks

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

daily use of the placebo chewable for 8 weeks

Intervention Type

Biological

Intervention Name(s)

Probiotic chewables

Intervention Description

chewables containing Lacticaseibacillus rhamnosus GG

Intervention Type

Biological

Intervention Name(s)

Placebo chewables

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

qPCR

Time Frame

at 8 weeks

Title

Changes in the score of allergic rhinitis symptoms

Description

Time Frame

over the study period (= 10 weeks)

Secondary Outcome Measure Information:

Title

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

Description

16S rRNA amplicon sequencing

Time Frame

baseline, 8 weeks

Title

Inlfuence on general nose- and mouth health

Description

Time Frame

baseline, 8 weeks, 10 weeks

Title

Changes in the absolute numbers of specific airway pathogens and viruses

Description

qPCR

Time Frame

baseline, 8 weeks

Title

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

Description

qPCR and/or ELISA

Time Frame

baseline, 8 weeks

Title

Frequency of medication use

Description

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

Time Frame

over the study period (= 10 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Lebeer, Prof

Organizational Affiliation

Universiteit Antwerpen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Olivier Vanderveken, Prof

Organizational Affiliation

University Hospital, Antwerp

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antwerp University Hospital

City

Edegem

Country

Belgium

12. IPD Sharing Statement

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Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

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