Phase
Condition
Rhinitis, Allergic, Perennial
Treatment
Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species)
Placebo Powder for Oral Solution
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 inthe last two years.
Positive skin prick test ≥5 mm for any of the following allergens: cat, dog andmites
Mean global score of miniRQLQ ≥ 2
TSS score of at least 7
Willing to discontinue consumption of fermented foods, probiotics (e.g., yogurtswith live, active cultures or supplements), prebiotics or immune-enhancingsupplements (e.g., Echinacea or fish oil).
Agreement on not starting new medication during the intervention (rescue medicationexcepted)
Women of childbearing potential with a negative pregnancy test throughout the studyperiod and highly effective contraception: oral contraceptives, condom withspermicide, intrauterine device, bilateral tubal ligation, vasectomized partner
Exclusion
Exclusion Criteria:
Non-allergic rhinitis
Use of any prohibited medication (any systemic corticosteroids, androgens such astestosterone, or high doses of anti-inflammatory drugs: i.e., aspirin in doses 600mg/d regularly) at the time of enrolment
Use of other probiotics-containing and prebiotics-containing products during theintervention 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 previousyear.
Other conditions that according to the investigator might interfere with theevaluation of the study objectives
Patients being treated for or had any of the following physician-diagnosed diseasesor conditions: HIV; immune modulating diseases (autoimmune disease, hepatitis,cancer, etc.); kidney disease; pancreatitis; pulmonary disease; hepatic or biliarydisease; 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 therun-in period
Study Design
Connect with a study center
ALYATEC clinical center
Strasbourg 2973783, Alyatec 67000
FranceActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.