Status:
RECRUITING
Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis
Lead Sponsor:
Winclove B.V.
Collaborating Sponsors:
Alyatec
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 alle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT07157462
Start Date
September 1 2025
End Date
April 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
ALYATEC clinical center
Strasbourg, Alyatec, France, 67000