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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Dietary supplement: Multistrain Probiotic; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giacomo Caio, MD, PhD; Phone Number: +39 0532236823; Email: caigmp@unife.it

Study Locations

• Italy
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Recruiting
      • Azienda Ospedaliero Universitaria di Ferrara
      • Contact: Caio Giacomo, MD, PhD; Phone Number: +390532236823; Email: caigmp@unife.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 8-week daily administration
Active Comparator: Mutistrain probiotic	Dietary supplement: Multistrain Probiotic; 8-week daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhinitis Control Assessment Test (RCAT)		over 8 weeks + 4 week after the end of trial (follow-up)
Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)		over 8 weeks + 4 week after the end of trial (follow-up)
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)
Serological markers	ECP, Eosinophil count, total IgE	over 8 weeks + 4 week after the end of trial (follow-up)

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Microbiota
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: AllergAway2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No