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

NCT07115342 | Recruiting

• 1 other identifier: 36264MS944/5/25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis; Allergic Rhinitis (AR)

Keywords

Nutritional Supplementation; Integrative Medicine; Vitamin D Deficiency; T Regulatory Cells; Th2 Inflammation; Immune Response; Anti-inflammatory; Lactobacillus; Bifidobacterium; Gut Microbiota; Complementary Therapy; Combined Supplementation; Clinical Trial; Quality of Life; Nasal Symptoms; Immunomodulation; Vitamin D; Probiotics; Allergic Rhinitis

Outcome Measures

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.

  From Baseline to Week 12 (End of Intervention)

Secondary Outcomes (3)

• Change in Serum Immunoglobulin E (IgE) Levels

  From Baseline to Week 12

• Change in Nasal Eosinophil Count

  From Baseline to Week 12

• Change in Serum Interleukin-13 (IL-13) and C-Reactive Protein (CRP)

  From Baseline to Week 12

Study Arms (2)

Control Group

EXPERIMENTAL

Drug: Standard Allergic Rhinitis Treatment

Combination Group

EXPERIMENTAL

Dietary Supplement: Combined Vitamin D and Probiotics Supplementation

Interventions

Standard Allergic Rhinitis Treatment DRUG

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

Control Group

Combined Vitamin D and Probiotics Supplementation DIETARY_SUPPLEMENT

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.

Combination Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital, ENT Department

Tanta, Gharbia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator, Clinical Pharmacy Department, Badr University in Cairo

Model Details: This study uses a parallel assignment model, in which participants are randomly assigned to one of two groups. Each group receives a different intervention (probiotics and vitamin D or standard care only), and participants remain in their assigned group for the entire 12-week study duration. There is no crossover between groups. This model allows researchers to directly compare the effects of each intervention and combination on allergic rhinitis symptoms and quality of life.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)