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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
ALYATEC clinical center
RECRUITING
Strasbourg
Contact Information
Primary
Kitty Maassen, PhD
k.maassen@winclove.nl
+31647210612
Backup
Maria Stolaki, MSc
m.stolaki@winclove.nl
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 98
Treatments
Active_comparator: Probiotic
Participants receive a multispecies probiotic formulation for oral use
Placebo_comparator: Placebo
The participants receive a placebo for oral use, comparable in appearance and smell as the probiotic formulation
Related Therapeutic Areas
Sponsors
Leads: Winclove B.V.
Collaborators: Alyatec

This content was sourced from clinicaltrials.gov