Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Egypt / NCT07115342
Recruiting Not applicable

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

NCT07115342 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Not applicable
Started
2025-08-01
Last updated
2025-08-14

Condition(s) studied

Allergic RhinitisAllergic Rhinitis (AR)

Investigational drug(s) / intervention(s)

Standard Allergic Rhinitis TreatmentCombined Vitamin D and Probiotics Supplementation

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Total Nasal Symptom Score (TNSS) and Quality of Life in Patients With Allergic Rhinitis — From Baseline to Week 12 (End of Intervention)
    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.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Hospital, ENT Department Tanta Gharbia Governorate Recruiting

More Tanta University trials in Egypt

Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery Starting soon
Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients Recruiting
Pelvic Floor Therapies for Lifelong Premature Ejaculation Recruiting
Carotid Artery Corrected Flow Time and Inferior Vena Cava Collapsibility Index for Prediction of Hypotension After Induction of General Anesthesia in Geriatric Patients Undergoing Elective Surgery Recruiting
Laparoscopic Management of Gastroesophageal Reflux Disease in Children Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07115342 on ClinicalTrials.gov ↗ ← All trials in Egypt