An interventional study of Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species) and Placebo Powder for Oral Solution in Perennial Allergic Rhinitis, sponsored by Winclove B.V.. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Winclove B.V. · Not applicable, Interventional, and Treatment
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.
180 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 7 are open to participants now.
This study's enrollment of 97 is below the median of 127 across 158 interventional studies indexed under Rhinitis, Allergic, Perennial.
Browse Rhinitis, Allergic, Perennial studies →This is the only study on the registry with Winclove B.V. as lead sponsor.
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Exclusion Criteria:
Participants receive a multispecies probiotic formulation for oral use
Dietary Supplement: Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species)
The participants receive a placebo for oral use, comparable in appearance and smell as the probiotic formulation
Dietary Supplement: Placebo Powder for Oral Solution
The probiotic powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks.
The 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
Time frame: From baseline to 12 weeks of intervention
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
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.
Time frame: From baseline to end of treatment at 12 weeks
Plan to share: No — Individual participant data (IPD) will not be shared. Only aggregated and anonymized data will be analyzed and reported. The individual participant data are collected and managed by the contract research organization (CRO) and remain confidential. Data will be presented in summary form in scientific publications and regulatory submissions only.
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