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

NCT ID: NCT05344352

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Allergic Rhinitis

Keywords

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Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mutistrain probiotic

Group Type ACTIVE_COMPARATOR

Multistrain Probiotic

Intervention Type DIETARY_SUPPLEMENT

8-week daily administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

8-week daily administration

Interventions

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Multistrain Probiotic

8-week daily administration

Intervention Type DIETARY_SUPPLEMENT

Placebo

8-week daily administration

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Giacomo Caio

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, Italy

Site Status

Countries

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Italy

Other Identifiers

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AllergAway2021

Identifier Type: -

Identifier Source: org_study_id