Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients
Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients
ClinicalTrials.gov ID: NCT05344352
Sponsor: Università degli Studi di Ferrara
Information provided by: Giacomo Caio, Università degli Studi di Ferrara (Responsible Party)
Last Update Posted: 2023-05-09
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.
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
Intervention / Treatment:
- Dietary Supplement: Multistrain Probiotic
- Other: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-03-30 |
| Primary Completion (Estimated) | 2023-12-31 |
| Study Completion (Estimated) | 2024-06-30 |
| Enrollment (Estimated) | 60 |
| Study Type | Interventional |
| Phase | Not Applicable |
| Other Study ID Numbers |
AllergAway2021 |