NCT07115342

Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis

Investigating Efficacy of Combined Probiotics and Vitamin D Supplementation in Reducing Symptoms and Improving Quality of Life in Patients With Allergic Rhinitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Allergic rhinitis (AR) is a common condition that causes nasal symptoms such as sneezing, runny nose, and congestion, often with itchy or watery eyes. It affects quality of life, sleep, work performance and increases healthcare use. Recent research suggests that the gut microbiome and immune regulation play important roles in allergic diseases. Probiotics may help by balancing gut bacteria and reducing inflammation. Vitamin D, which supports immune function, is often low in people with allergies and may help improve symptoms. While probiotics and vitamin D have each been studied separately in AR, their combined effect has not been well investigated. This study aims to evaluate whether combining these supplements with standard care is more effective than using either supplement alone or standard care alone. This is a randomized, controlled, 2-arm clinical trial. Adult participants with moderate to severe allergic rhinitis will be randomly assigned to one of four groups: * Standard care (control group) * Standard care + probiotics + vitamin D Supplements will be taken for 12 weeks. The study will measure symptom severity, quality of life, and changes in certain immune markers. The findings may offer new insights into effective, low-risk, and accessible options to support allergic rhinitis management.

Conditions

• Allergic Rhinitis
• Allergic Rhinitis (AR)

Interventions

Type	Name	Description
DRUG	Standard Allergic Rhinitis Treatment	Participants 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
DIETARY_SUPPLEMENT	Combined Vitamin D and Probiotics Supplementation	Participants 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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-30
• Completion: 2025-11-30
• First posted: 2025-08-11
• Last updated: 2025-08-14

Locations

1 site across 1 country: Egypt