Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis

Winclove B.V.98 enrolled

Overview

The goal of this clinical trial is to learn if a probiotic formulation consisting of multiple bacterial strains has a positive effect on the quality of life of participants with chronic perennial allergic rhinitis symptoms. The researchers will also study whether the probiotic formulation influences the symptoms of allergic rhinitis. Participants with allergies to house dust mite, cats and/or dogs will be included in the study. The main questions it aims to answer are: Does the probiotic formulation have an impact of the quality of life of the participants? Does the probiotic formaluation have an effect on the severity of the symptoms of allergic rhinitis? Are there differences in the effects depending on the allergies the participants have? Researchers will compare the probiotic formulation to a placebo (a substance that contains no probiotic bacteria but looks, smells, and tastes the same) to see if the probiotic formulation improves the quality of life of participants with chronic allergic rhinitis. In addition, also a GI symptom questionnaire will be filled in by the participants weekly Participants will visit the clinic for the screening, and at the start, and at the end of the intervention for checkups and sampling. During the intervention they will take the probiotic formulation or a placebo twice every day for 12 weeks. They will keep a diary of their symptoms and note whenever they use anti-histamines and every two weeks they will fill in a questionnaire about their quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Perennial Allergic Rhinitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged ≥18 years * Willing and able to provide informed consent in French * Persistent perennial allergic rhinitis induced by a least one perennial allergen in the last two years. * Positive skin prick test ≥5 mm for any of the following allergens: cat, dog and mites * Mean global score of miniRQLQ ≥ 2 * TSS score of at least 7 * Willing to discontinue consumption of fermented foods, probiotics (e.g., yogurts with live, active cultures or supplements), prebiotics or immune-enhancing supplements (e.g., Echinacea or fish oil). * Agreement on not starting new medication during the intervention (rescue medication excepted) * Women of childbearing potential with a negative pregnancy test throughout the study period and highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner Exclusion Criteria: * Non-allergic rhinitis * Use of any prohibited medication (any systemic corticosteroids, androgens such as testosterone, or high doses of anti-inflammatory drugs: i.e., aspirin in doses 600 mg/d regularly) at the time of enrolment * Use of other probiotics-containing and prebiotics-containing products during the intervention period and 4 weeks before study start * Use of any antibiotics 6 weeks before randomization * Nasal polyposis * Currently enrolled in another intervention study (except observational studies) * Critically or terminally ill or admitted to the ICU * Had received chemotherapy or other immune-suppressing therapy within the previous year. * Other conditions that according to the investigator might interfere with the evaluation of the study objectives * Patients being treated for or had any of the following physician-diagnosed diseases or conditions: HIV; immune modulating diseases (autoimmune disease, hepatitis, cancer, etc.); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases or conditions, such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including gastroesophageal reflux disease, * Subjects with a low compliance rate (appreciated by the investigator) during the run-in period

Outcomes

Primary Outcomes

The primary efficacy endpoint is the change in the global score of the mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) from baseline to week 12 of intervention

An improvement on quality of life is considered clinically meaningful when improved with ≥0.7 points in global and domain-specific mini-RQLQ scores between intervention and placebo

Time frame: From baseline to 12 weeks of intervention

Secondary Outcomes

The impact of intervention in rhino conjunctivitis quality of life will be assessed by the changes in global and domain-specific mini-RQLQ scores from baseline to week 12 of intervention every two weeks.

Time frame: Every two weeks from baseline to end of treatment at 12 weeks

The proportion of participants reporting a clinical relevant improvement on quality of life in global and domain-specific mini-RQLQ scores between intervention and placebo

The proportion of participants reporting a clinical relevant improvement on quality of life will be assessed by the difference in proportion of participants achieving a clinically meaningful improvement (≥0.7 points) in global and domain-specific mini-RQLQ scores between intervention and placebo

Time frame: From baseline to end of treatment at 12 weeks

The proportion of participants reporting a clinical relevant improvement on allergic rhinoconjuctivitis symptoms in global and domain-specific TSS scores between intervention and placebo

The proportion of participants reporting a clinical relevant improvement on allergic rhinoconjuctivitis symptoms will be assessed by the difference in proportion of participants achieving a clinically meaningful improvement (≥20%) in global and domain-specific TSS scores between intervention and placebo

Time frame: From baseline to end of treatment at 12 weeks

The impact of a multispecies probiotic formulation on allergic rhinoconjunctivitis severity will be assessed by the difference in TSS mean (global and per item) between intervention and placebo over 12 weeks.

Time frame: From baseline to end of treatment at 12 weeks, daily

The impact of a multispecies probiotic formulation on allergic rhinoconjunctivitis severity with established perennial allergies will be assessed as the change in the global score of the TSS from baseline to week 12 of intervention.

Time frame: From baseline to end of treatment at 12 weeks

Differences in TSS will be analysed in subgroups of participants based on type of allergy

Differences in TSS will be analysed in subgroups of participants based on type of allergy (HDM, HDM+Cat, HDM+Cat+Dog, Cat, Cat+Dog and Dog)

Time frame: From baseline to end of treatment at 12 weeks, daily

Differences in TSS will be analysed in subgroups of participants based on allergy pattern

Differences in TSS will be analysed in subgroups of participants based on different allergy pattern (perennial vs perennial with seasonal allergies)

Time frame: From baseline to end of treatment at 12 weeks, daily

Differences in TSS will be analysed in subgroups of participants based on baseline severity of TSS score

Differences in TSS will be analysed in subgroups of participants based on baseline severity as stratified by TSS scores as follows: 0-6 = mild, 7-12=moderate, 13-18 =moderate/severe, and 19-24= severe

Time frame: From baseline to end of treatment at 12 weeks, daily

Differences in mini-RQLQ will be analysed in subgroups of participants based on type of allergy

Differences in mini-RQLQ will be analysed in subgroups of participants based on type of allergy (HDM, HDM+Cat, HDM+Cat+Dog, Cat, Cat+Dog and Dog)

Time frame: From baseline to end of treatment at 12 weeks, two weekly

Differences in mini-RQLQ will be analysed in subgroups of participants based on allergy pattern

Differences in mini-RQLQ will be analysed in subgroups of participants based on on different allergy pattern (perennial vs perennial with seasonal allergies)

Time frame: From baseline to end of treatment at 12 weeks, two weekly

Differences in mini-RQLQ will be analysed in subgroups of participants based on baseline severity of mini-RQLQ

Differences in mini-RQLQ will be analysed in subgroups of participants based on baseline severity as stratified by mini-RQLQ as follows: 0-1.5, 1.5-2.5, 2.5-3.5, 3.5-4.5, \>4.5

Time frame: From baseline to end of treatment at 12 weeks, two weekly

Change in immune modulatory biomarkers (cytokines and IgE) at baseline compared to 12 weeks of intervention versus placebo

Time frame: From baseline to end of treatment at 12 weeks

Change in amount of blood cells at baseline compared to 12 weeks of intervention versus placebo

Time frame: From baseline to end of treatment at 12 weeks

Change in ratio of blood cell at baseline compared to 12 weeks of intervention versus placebo

Time frame: From baseline to end of treatment at 12 weeks

Change in rescue medication use (antihistamines) will be expressed as a percentage of the completed daily diary entries over the 12 weeks intervention period

Time frame: From baseline to end of treatment

Reduction in gastro-intestinal complaints will be assessed using the GSRS questionnaire after 12 weeks intervention versus placebo and across weekly time points

Time frame: From baseline to end of treatment at 12 weeks and weekly between those timepoints

Reduction in allergic symptoms other than rhinitis (eczema, food allergy and intolerance) using Non-rhinoconjunctivitis allergy Questionnaire over the 12 weeks intervention versus placebo

Time frame: From baseline to end of treatment at 12 weeks

Change in fecal microbiome profile or metabolites production (e.a SCFA and bile acids) will be analyzed after 12 weeks intervention versus placebo

Time frame: From baseline to end of treatment at 12 weeks

Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts