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RECRUITING

NCT07115342

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

Sponsor: Tanta University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-08-01

Completion Date

2025-11-30

Last Updated

2025-08-14

Healthy Volunteers

Conditions

Allergic Rhinitis Allergic Rhinitis (AR)

Interventions

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.

Inclusion Criteria: Confirmed diagnosis of AR based on clinical history and specific IgE testing or will be screened for eligibility by the modified Mini Rhino-conjunctivitis Quality of Life Questionnaire (Mini RQLQ). Persistent rhinitis symptoms for at least two consecutive years. Presence of two or more AR symptom domains, including sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms persisting or accumulating for more than 1 hour daily with \> 2 scores without taking medication. Symptoms may be accompanied by ocular manifestations such as eye itching, tearing, and redness Voluntarily and in writing, sign an informed consent form agreeing to participate in this study and able to complete the study as required by the trial protocol. Vitamin D insufficiency or deficiency. Deficiency: \< 20 ng/mL (\< 50 nmol/L), Insufficiency: 20-29 ng/mL (50-75 nmol/L) Exclusion Criteria: Use of systemic corticosteroids, immunosuppressive therapy, or medications affecting the gut microbiota (antimicrobials, probiotics, prebiotics, intestinal mucosal protective agents, etc.) within 4 weeks prior to screening. Regular use of probiotics, prebiotics, or vitamin D supplements within 6 months prior to screening. History of or concurrent use of medications or supplements that alter serum 25(OH)D levels, such as barbiturates, bisphosphonates, sulfasalazine, anticonvulsants, antiretrovirals, omega-3 supplements, or ketoconazole. Diagnosed with pulmonary tuberculosis, allergic asthma, chronic obstructive pulmonary disease (COPD), mast cell activation syndrome, or other respiratory diseases requiring treatment. Coexisting conditions such as nasal polyps, severe nasal septum deviation, severe gastrointestinal diseases (e.g., severe diarrhea or inflammatory bowel diseases), metabolic syndrome (e.g., obesity, dyslipidemia, hypertension, diabetes), or chronic systemic diseases or malignancies. History of autoimmune diseases or chronic inflammatory conditions. Sinusitis, otitis media, or respiratory tract infections or upper respiratory infections within 14 days of the study start. Known hypersensitivity or allergy to any component of the probiotics or other study interventions. Physical signs or symptoms suggestive of renal, hepatic, or cardiovascular disease. Pregnant or lactating women.

Locations (1)

Tanta University Hospital, ENT Department

Tanta, Gharbia Governorate, Egypt