Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07115342

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

Led by Tanta University · Updated on 2025-08-14

120

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of allergic rhinitis based on clinical history and specific IgE testing or screening by modified Mini Rhino-conjunctivitis Quality of Life Questionnaire
  • Persistent rhinitis symptoms for at least two consecutive years
  • Presence of two or more allergic rhinitis symptom domains 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
  • Signed written informed consent and ability to complete the study as required
  • Vitamin D insufficiency or deficiency (deficiency: < 20 ng/mL; insufficiency: 20-29 ng/mL)
Not Eligible

You will not qualify if you...

  • Use of systemic corticosteroids, immunosuppressive therapy, 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 that alter serum 25(OH)D levels (e.g., barbiturates, bisphosphonates, anticonvulsants) prior to screening
  • Diagnosed with pulmonary tuberculosis, allergic asthma, COPD, mast cell activation syndrome, or other respiratory diseases needing treatment
  • Coexisting nasal polyps, severe nasal septum deviation, severe gastrointestinal diseases, metabolic syndrome, chronic systemic diseases, or malignancies
  • History of autoimmune diseases or chronic inflammatory conditions
  • Sinusitis, otitis media, or respiratory infections within 14 days before study start
  • Known allergy or hypersensitivity to probiotics or other study interventions
  • Signs or symptoms of kidney, liver, or heart disease
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tanta University Hospital, ENT Department

Tanta, Gharbia Governorate, Egypt

Actively Recruiting

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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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