Perennial Allergic RhinitisAllerGoNCT07157462
Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis
A study testing Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species) in people with Perennial Allergic Rhinitis, run by Winclove B.V. at 1 site in France.
Trial 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 allergic rhinitis symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 19 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Perennial Allergic Rhinitis
- Being tested
- Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species), Placebo Powder for Oral Solution
- Keywords
- Multispecies probiotic, House dust mite allergy, cat and dog allergy
- Medical subject headings
- Rhinitis, Allergic, Perennial, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species)Dietary supplement
The probiotic powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks.
Placebo Powder for Oral SolutionDietary supplement
The placebo powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Participants receive a multispecies probiotic formulation for oral use Receives: Dietary Supplement: Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species) |
| Placebo | Placebo comparator | The participants receive a placebo for oral use, comparable in appearance and smell as the probiotic formulation Receives: Dietary Supplement: Placebo Powder for Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 12 weeks of intervention
Secondary outcomes (18)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Sep 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winclove B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alyatec
- Responsible party
- Sponsor
- Investigators
- Alina GHERASIM, MD, Principal investigator, ALYATEC clinical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157462
- Sponsor's protocol ID
- WIN-001
- Acronym
- AllerGo
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.