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

NCT07157462 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species)

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

DIETARY_SUPPLEMENT

Placebo Powder for Oral Solution

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

Sponsors & Collaborators

  • Alyatec

    collaborator INDUSTRY

  • Winclove B.V.

    lead INDUSTRY

Principal Investigators

  • Alina GHERASIM, MD · ALYATEC clinical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07157462 on ClinicalTrials.gov