Multispecies probiotic for perennial allergic rhinitis
Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis
NA · Winclove B.V. · NCT07157462
This will try a six‑strain oral probiotic powder versus a matched placebo to see if it improves symptoms and quality of life in adults with year‑round allergic rhinitis from dust mites, cats, or dogs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Winclove B.V. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Strasbourg, Alyatec) |
| Trial ID | NCT07157462 on ClinicalTrials.gov |
What this trial studies
Adults with persistent perennial allergic rhinitis and a positive skin prick to mites, cats, or dogs will be assigned to receive either a multispecies probiotic powder or a matched placebo for the intervention period. Key outcomes include change in quality of life (miniRQLQ) and symptom severity (total symptom score, TSS), and investigators will look for differences by specific allergen sensitization. Participants must stop other probiotics, fermented foods, prebiotics, and certain supplements during the study, and follow contraception and medication restrictions. The study compares the probiotic formulation directly against placebo to determine any clinical benefit.
Who should consider this trial
Good fit: Adults (≥18) with persistent perennial allergic rhinitis for at least two years, a positive skin prick (≥5 mm) to cat, dog, or mites, a miniRQLQ global score ≥2 and TSS ≥7, who can consent in French and stop other probiotics/fermented foods and follow contraceptive requirements.
Not a fit: People with non‑allergic rhinitis, children, pregnant women, those using prohibited systemic medications (e.g., recent systemic corticosteroids), or those unable to stop probiotic/fermented food intake are unlikely to benefit from participating.
Why it matters
Potential benefit: If effective, the probiotic could reduce symptom severity and improve quality of life for people with perennial allergic rhinitis.
How similar studies have performed: Previous probiotic trials for allergic rhinitis have produced mixed results, with some small studies showing modest improvements in symptoms or quality of life but no consistent consensus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Strasbourg, Alyatec
- ALYATEC clinical center — Strasbourg, Alyatec, France (RECRUITING)
Study contacts
- Principal investigator: Alina GHERASIM, MD — ALYATEC clinical center
- Study coordinator: Kitty Maassen, PhD
- Email: k.maassen@winclove.nl
- Phone: +31647210612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perennial Allergic Rhinitis, Multispecies probiotic, House dust mite allergy, cat and dog allergy