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.
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
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
Parallel
Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species)
Dietary supplementThe probiotic powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks.
Placebo Powder for Oral Solution
Dietary supplementThe placebo powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks.
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
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.
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
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
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.
Correlation between change from baseline in GSRS total score and changes in gut microbiome composition and fecal metabolite concentrations at Week 12
Associations between gastrointestinal symptom changes, as measured by the Gastrointestinal Symptom Rating Scale (GSRS; 15 items, 7-point Likert scale), and changes in gut microbiome composition and fecal metabolite concentrations will be explored. Microbiome profiling will be performed using 16S rRNA sequencing of stool samples, and metabolite analysis will include short-chain fatty acids (SCFAs), bile acids, and other metabolites identified through untargeted metabolomics. Correlation analyses (e.g., Spearman's rank correlation) and/or linear regression models will be applied. Additional multivariate or network analyses may be used to explore complex interaction patterns. These analyses are exploratory and hypothesis-generating; no formal adjustment for multiple testing will be applied.
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Winclove B.V.
Lead sponsor
Alyatec
Collaborator
