Actively Recruiting
Effect of Combined Probiotics and Vitamin D on Symptoms and Quality of Life in Adults With Allergic Rhinitis
Led by Tanta University · Updated on 2025-08-14
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether taking probiotics, vitamin D, or both together can help reduce symptoms and improve quality of life for adults with allergic rhinitis (AR), a condition causing sneezing, nasal congestion, and itchy or watery eyes. This randomized, controlled study includes adults with moderate to severe AR who may have vitamin D insufficiency or deficiency. The goal is to understand if adding these supplements to standard treatment improves symptom severity and quality of life. Participants will be randomly assigned to either standard care alone or standard care plus a combination of vitamin D and probiotics. Those in the combination group will take a daily probiotic capsule and vitamin D tablet for 12 weeks, alongside their usual AR treatments such as antihistamines or nasal sprays. The study aims to assess the combined effect of these supplements on immune markers and symptom relief. During the study, participants will visit the clinic for checkups and lab tests including measurements of nasal symptoms, quality of life surveys, and blood tests for immune markers like IgE and interleukin-13. Researchers will monitor changes from the start of the study through week 12. The findings may provide insight into accessible ways to support management of allergic rhinitis. Participation lasts for 12 weeks of supplementation and observation.
CONDITIONS
Brief Title
Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of allergic rhinitis based on clinical history and specific IgE testing or screening by the Mini Rhino-conjunctivitis Quality of Life Questionnaire
- Persistent rhinitis symptoms for at least two consecutive years
- Presence of two or more allergic rhinitis symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion lasting more than 1 hour daily without medication
- Symptoms may include eye itching, tearing, and redness
- Voluntarily sign informed consent and able to complete the study protocol
- Vitamin D insufficiency or deficiency (less than 30 ng/mL blood level)
You will not qualify if you...
- Use of systemic corticosteroids, immunosuppressive drugs, or medications affecting gut microbiota within 4 weeks before screening
- Regular use of probiotics, prebiotics, or vitamin D supplements within 6 months before screening
- Use of medications or supplements affecting vitamin D levels such as barbiturates or anticonvulsants
- Diagnosed pulmonary tuberculosis, allergic asthma, COPD, mast cell activation syndrome, or other respiratory diseases needing treatment
- Nasal polyps, severe nasal septum deviation, severe gastrointestinal diseases, metabolic syndrome, chronic systemic diseases, or malignancies
- History of autoimmune or chronic inflammatory diseases
- Sinusitis, otitis media, or respiratory infections within 14 days before study start
- Known allergy to probiotics or study interventions
- Signs of kidney, liver, or heart disease
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take daily supplements of Vitamin D3 and probiotics along with standard allergic rhinitis treatment, or standard treatment alone, to evaluate effects on symptoms and quality of life.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
Tanta University Hospital, ENT Department
Tanta, Gharbia Governorate, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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