Skip to main content
OpenTrials
Completed

NCT Number: NCT05344352

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multistrain probiotic

Dietary Supplement

8-week daily administration

Placebo

Other

8-week daily administration

Primary outcomes

  1. Total nasal symptom score (TNSS)

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

    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 outcomes

  1. Rhinitis Control Assessment Test (RCAT)

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

  2. Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)

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

  3. Gut Microbiota changes on fecal samples

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

    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.

  4. Serological markers

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

    ECP, Eosinophil count, total IgE

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 25, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.