Investigation of the Effects of a Multispecies Probiotic Formulation on Perennial Allergic Rhinitis

NCT07157462 | Recruiting

• 1 other identifier: WIN-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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 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

Perennial Allergic Rhinitis

Keywords

Multispecies probiotic; House dust mite allergy; cat and dog allergy

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

  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

  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.

  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.

  From baseline to end of treatment at 12 weeks

Other Outcomes (1)

• Correlation between change from baseline in GSRS total score and changes in gut microbiome composition and fecal metabolite concentrations at Week 12

  From baseline to end of treatment at 12 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Participants receive a multispecies probiotic formulation for oral use

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

Dietary Supplement: Placebo Powder for Oral Solution

Interventions

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.

Probiotic

Placebo Powder for Oral Solution DIETARY_SUPPLEMENT

The placebo powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Winclove B.V.: lead
• Alyatec: collaborator

Study Sites (1)

ALYATEC clinical center

Strasbourg, Alyatec, 67000, France

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Dust Mite Allergy

Interventions

Lacteol; Solutions

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Alina GHERASIM, MD

  ALYATEC clinical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kitty Maassen, PhD

CONTACT

+31647210612; k.maassen@winclove.nl

Maria Stolaki, MSc

CONTACT

m.stolaki@winclove.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)