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

NCT05344352 | Completed DMC

• 1 other identifier: AllergAway2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  over 8 weeks + 4 week after the end of trial (follow-up)

• Serological markers

  over 8 weeks + 4 week after the end of trial (follow-up)

Study Arms (2)

Mutistrain probiotic

ACTIVE COMPARATOR

Dietary Supplement: Multistrain Probiotic

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Multistrain Probiotic DIETARY_SUPPLEMENT

8-week daily administration

Mutistrain probiotic

Placebo OTHER

8-week daily administration

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 25, 2022
• Study Start: March 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)