Investigating the Efficacy of Probiotic Supplementation in the Management of Allergic Rhinitis: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Arupadai Veedu Medical College and Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To asses Effectiveness of reducing symptoms and immunology marker levels .i.e. AEC count and Ige and diagnostic nasal endoscopy using probiotics as an adjunct with standard treatment for patients having Allergic Rhinitis.
Overview
Brief Summary
Allergic rhinitis is a common inflammatory condition of the nasal mucosa, characterized by symptoms such as nasal congestion, rhinorrhoea, sneezing, and nasal itching, often triggered by allergens. It affects a noteworthy portion of the population worldwide, leading to impaired quality of life, productivity losses, and substantial healthcare costs. The current standard treatments for allergic rhinitis include antihistamines, intranasal corticosteroids, and allergen immunotherapy.
Recent research has increasingly focused on the role of the gut microbiota in modulating immune responses and inflammatory conditions, including allergic diseases.
Probiotics, are defined as live microorganisms that offer health benefits when administered in adequate amounts.
Several studies have suggested that specific probiotic strains can promote immune tolerance and reduce allergic responses.
Despite the promising evidence we have failed to document the evidence of the use of probiotics in individuals with allergic rhinitis in the area specific to Pondicherry and Cuddalore of Tamil Nadu.
This study aims to contribute to the growing body of evidence by conducting a randomized controlled trial to investigate the impact of probiotics on allergic rhinitis symptoms and immune markers.
Aim
- To asses Effectiveness of reducing symptoms and immunology marker levels .i.e. AEC count and Ige using probiotics as an adjunct with standard treatment for patients having Allergic Rhinitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 18 upto 50 years attending ENT OPD in AVMC presenting with symptoms of allergic rhinitis with blood investigations supporting the diagnosis of allergic rhinitis.
Exclusion Criteria
- •Patients with a history of severe allergic reactions or other significant comorbidities.
- •Patients currently using probiotics or undergoing immunomodulatory therapy.
- •Pregnant or lactating women.
- •Patients previously diagnosed with GERD.
Outcomes
Primary Outcomes
To asses Effectiveness of reducing symptoms and immunology marker levels .i.e. AEC count and Ige and diagnostic nasal endoscopy using probiotics as an adjunct with standard treatment for patients having Allergic Rhinitis.
Time Frame: To asses Effectiveness of reducing symptoms and immunology marker levels at 2 weeks , 4 weeks ,6 weeks
Secondary Outcomes
- To establish the association of Laryngeal reflux/Gastro- oesophageal reflux with allergic rhinitis.(at 2 weeks , 4 weeks ,6 weeks)
Investigators
Dr Bhairavi Sharma
Aarupadai Veedu Medical College and Hospital