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

Primary Purpose

Allergic Rhinitis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Multistrain Probiotic

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Microbiota

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Azienda Ospedaliero Universitaria di FerraraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mutistrain probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rhinitis Control Assessment Test (RCAT)

Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)

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.

Serological markers

ECP, Eosinophil count, total IgE

Full Information

NCT ID

NCT05344352

First Posted

March 30, 2022

Last Updated

May 8, 2023

Sponsor

Università degli Studi di Ferrara

1. Study Identification

Unique Protocol Identification Number

NCT05344352

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi di Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Microbiota

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mutistrain probiotic

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Multistrain Probiotic

Intervention Description

8-week daily administration

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

8-week daily administration

Primary Outcome Measure Information:

Title

Total nasal symptom score (TNSS)

Description

Time Frame