Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University
About this trial
The goal of this clinical trial is to learn if taking probiotics, vitamin D, or both together can help lower symptoms of allergic rhinitis (AR) and improve quality of life in adults. Allergic rhinitis is a condition that causes sneezing, nasal congestion, and itchy or watery eyes.
The main questions this study aims to answer are:
• Do these supplements improve the quality of life for people with AR?
Researchers will compare four groups:
* People taking probiotics and vitamin D * People receiving standard treatment only (control group)
Participants will:
* Take a probiotic capsule daily and/or a vitamin D tablet (based on blood levels) for 12 weeks * Continue standard allergic rhinitis treatment (like antihistamines or nasal sprays) * Visit the clinic for checkups and lab tests * Complete surveys about their symptoms and quality of life
This study will help researchers understand if adding probiotics and/or vitamin D to standard care can help people with allergic rhinitis feel better.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Allergic Rhinitis Treatment
DrugParticipants will receive standard-of-care treatment for allergic rhinitis, including oral antihistamines and/or intranasal corticosteroids, according to current clinical guidelines. No additional supplementation will be provided in the control group. This arm serves as the comparator for evaluating the effects of probiotic and vitamin D supplementation
Combined Vitamin D and Probiotics Supplementation
Dietary supplementParticipants in this group will receive a combination therapy of Vitamin D3 plus a daily oral probiotic capsule containing a standardized blend of Lactobacillus and Bifidobacterium species. Both supplements will be administered once daily for 12 weeks. This intervention aims to assess the synergistic effect of vitamin D and probiotics on immune response and symptom relief in allergic rhinitis.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Control GroupExperimental treatment 1 intervention
Group B: Combination GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Total Nasal Symptom Score (TNSS) and Quality of Life in Patients With Allergic Rhinitis
TNSS is a validated clinical scale measuring four core nasal symptoms (itching, congestion, sneezing, and runny nose), each scored from 0 (none) to 3 (severe), with a total score range of 0-12. The Rhinitis Quality of Life Questionnaire (RQLQ) will assess patient-reported quality of life related to allergic rhinitis, including daily activity limitations, nasal and eye symptoms, sleep disturbance, and emotional well-being.
Time frame
From Baseline to Week 12 (End of Intervention)Secondary outcomes
1
Change in Serum Immunoglobulin E (IgE) Levels
Total IgE concentration will be measured using ELISA from venous blood samples at baseline and after 12 weeks to assess allergic sensitization and systemic immune response.
Time frame
From Baseline to Week 122
Change in Nasal Eosinophil Count
Nasal smear cytology will be used to quantify eosinophil presence, an indicator of allergic inflammation.
Time frame
From Baseline to Week 123
Change in Serum Interleukin-13 (IL-13) and C-Reactive Protein (CRP)
Serum inflammatory markers IL-13 and CRP will be measured to assess changes in systemic and allergic inflammation.
Time frame
From Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov