Clinical trial NCT05344352: Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients
Official title: Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Sintomi Della Rinite Allergica Perenne E Stagionale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Microbiota
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to evaluate the efficacy of administering a multistrain probiotic in adult human subjects suffering from allergic rhinitis and evaluate both symptomatology through validated questionnaires and gut microbiota modification during and after treatment.

Detailed description: Adult subjects (18-60) with documented allergic rhinitis will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks. Total nasal symptom score (TNSS), Rhinitis Control Assessment Test (RCAT), Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) will be compared over 12 weeks between the two treatment groups. In addition, serological markers (Eosinophil count, Total IgE and Eosinophilic cationic protein) and gut microbiota features will be evaluated over a 12 week period.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 65 years of age
* Established allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis \>2 years)
* Positive Skin Prick Test and/or Specific IgE to at least one aeroallergen.
* Have signed the consent form
* Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period

Exclusion Criteria:

* Subjects currently under treatment with antibiotics
* Subjects undergoing allergen immunotherapy
* Pregnancy
* Vasomotor rhinitis
* Nasal cavity disorders
* Ear infections
* Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
* Subjects diagnosed with non-controlled asthma
* Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
* Subjects on chronic use of systemic corticosteroids
* Proton pump inhibitors 2-weeks prior to randomization
* Antibiotics 2-weeks prior to randomization

Primary outcomes:
measure: Total nasal symptom score (TNSS)
timeFrame: over 8 weeks + 4 week after the end of trial (follow-up)
Secondary outcomes:
measure: Rhinitis Control Assessment Test (RCAT)
timeFrame: over 8 weeks + 4 week after the end of trial (follow-up)
measure: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)
timeFrame: over 8 weeks + 4 week after the end of trial (follow-up)
measure: Gut Microbiota changes on fecal samples
timeFrame: over 8 weeks + 4 week after the end of trial (follow-up)
measure: Serological markers
timeFrame: over 8 weeks + 4 week after the end of trial (follow-up)
Other outcomes:
Locations:
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
state: Ferrara
Study officials:
References: