Actively Recruiting
Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis
Led by Winclove B.V. · Updated on 2025-11-24
98
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Winclove B.V.
Lead Sponsor
A
Alyatec
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a probiotic formulation containing multiple bacterial strains can improve the quality of life and reduce symptoms in adults with chronic perennial allergic rhinitis caused by allergies to house dust mites, cats, or dogs. The study compares the effects of the probiotic to a placebo to understand if it influences allergic rhinitis symptoms and quality of life, with attention to differences based on the types of allergies participants have. Participants will take either the probiotic formulation or a placebo twice daily for 12 weeks. The probiotic and placebo powders are provided in sachets to be dissolved in water before ingestion. The study includes a screening visit, a start visit, and an end-of-intervention visit for checkups and sample collection. Participants will also complete weekly gastrointestinal symptom questionnaires and keep a diary of symptoms and antihistamine use throughout the intervention. Throughout the study, researchers will assess changes in quality of life using the mini-Rhinoconjunctivitis Quality of Life Questionnaire and measure allergic rhinitis symptoms daily. They will monitor use of rescue medication and collect blood and fecal samples to analyze immune markers and microbiome changes. Questionnaires on gastrointestinal symptoms and other allergic conditions will be completed regularly. The total participation period includes 12 weeks of intervention with ongoing assessments to evaluate the probiotic's impact.
CONDITIONS
Brief Title
Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 518 years
- Able and willing to provide informed consent in French
- Persistent perennial allergic rhinitis caused by at least one perennial allergen in the last two years
- Positive skin prick test of 5 mm or larger for cat, dog, or mites allergens
- Mean global miniRQLQ score of 2 or higher
- Total Symptom Score (TSS) of at least 7
- Willing to stop consuming fermented foods, probiotics, prebiotics, or immune-enhancing supplements during the study
- Agree not to start new medications during the intervention, except rescue medication
- Women of childbearing potential must have negative pregnancy tests throughout the study and use highly effective contraception methods
You will not qualify if you...
- Non-allergic rhinitis
- Use of prohibited medications such as systemic corticosteroids, androgens (testosterone), or high doses of anti-inflammatory drugs at enrollment
- Use of probiotics or prebiotics products during the intervention period or 4 weeks before
- Use of any antibiotics in the 6 weeks before randomization
- Nasal polyposis
- Current participation in another intervention study (except observational studies)
- Critically or terminally ill or admitted to intensive care
- Received chemotherapy or immune-suppressing therapy within the last year
- Conditions that may interfere with study evaluation as judged by the investigator
- Diagnosed with diseases such as HIV, autoimmune diseases, hepatitis, cancer, kidney disease, pancreatitis, pulmonary, hepatic, biliary, or certain gastrointestinal diseases except gastroesophageal reflux disease
- Low compliance during the run-in period as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants ingest a multispecies probiotic powder or placebo dissolved in water twice daily to assess its effects on perennial allergic rhinitis.
Visits every two weeks for assessments; daily symptom diary entries during treatment
Trial Site Locations
Total: 1 location
1
ALYATEC clinical center
Strasbourg, Alyatec, France, 67000
Actively Recruiting
Research Team
K
Kitty Maassen, PhD
M
Maria Stolaki, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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