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
30 weeks
Total Duration
On this page
Sponsors
W
Winclove B.V.
Lead Sponsor
A
Alyatec
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 8 years or older
- 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 5 mm for cat, dog, or mites allergens
- Mean global score of mini-RQLQ at least 2
- Total symptom score of at least 7
- Willing to stop consuming fermented foods, probiotics, prebiotics, or immune-enhancing supplements
- Agree not to start new medications during the intervention (except rescue medication)
- Women of childbearing potential must have negative pregnancy tests throughout and use highly effective contraception
You will not qualify if you...
- Having non-allergic rhinitis
- Using prohibited medications such as systemic corticosteroids, androgens, or high-dose anti-inflammatory drugs at enrollment
- Use of probiotics or prebiotics products during intervention and 4 weeks before study start
- Use of antibiotics within 6 weeks before randomization
- Presence of nasal polyposis
- Currently enrolled in another intervention study (except observational)
- Critically or terminally ill, or admitted to ICU
- Received chemotherapy or immune-suppressing therapy within the last year
- Conditions interfering with study evaluation as judged by investigator
- Diagnosed with HIV, autoimmune diseases, hepatitis, cancer, kidney disease, pancreatitis, pulmonary disease, hepatic or biliary disease, or certain gastrointestinal diseases excluding GERD
- Low compliance rate during run-in period as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
ALYATEC clinical center
Strasbourg, Alyatec, France, 67000
Actively Recruiting
Research Team
K
Kitty Maassen, PhD
CONTACT
M
Maria Stolaki, MSc
CONTACT
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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