Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344352
• Other study ID #: AllergAway2021
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Università degli Studi di Ferrara
• Contact: Giacomo Caio, MD, PhD
• Phone: +39 0532236823
• Email: caigmp[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Dietary Supplement:
• Multistrain Probiotic
8-week daily administration

Other:
• Placebo
8-week daily administration

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria di Ferrara	Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total nasal symptom score (TNSS)	Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups + after 4 weeks from the end of trial.	over 8 weeks + 4 week after the end of trial (follow-up)
Secondary	Rhinitis Control Assessment Test (RCAT)		over 8 weeks + 4 week after the end of trial (follow-up)
Secondary	Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)		over 8 weeks + 4 week after the end of trial (follow-up)
Secondary	Gut Microbiota changes on fecal samples	Shotgun metagenomic sequencing and computational profiling with the tools in bioBAkery3. MetaPhlAn3.0 and HUMAnN3.0 will be used for taxonomic and functional profiling. Only the species showing a non-zero abundance in =5% of the samples will be considered in the cross-sectional and longitudinal analysis. P-values will be corrected for multiple hypothesis testing with Benjamini-Hochberg FDR procedure, and the longitudinal analysis was performed using a linear mixed-effects model.	over 8 weeks + 4 week after the end of trial (follow-up)
Secondary	Serological markers	ECP, Eosinophil count, total IgE	over 8 weeks + 4 week after the end of trial (follow-up)