An interventional study of Standard Allergic Rhinitis Treatment and Combined Vitamin D and Probiotics Supplementation in Allergic Rhinitis and Allergic Rhinitis (AR), sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Tanta University · Not applicable, Interventional, and Supportive care
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:
Researchers will compare four groups:
Participants will:
This study will help researchers understand if adding probiotics and/or vitamin D to standard care can help people with allergic rhinitis feel better.
Allergic rhinitis (AR) is a common condition that causes nasal symptoms such as sneezing, runny nose, and congestion, often with itchy or watery eyes. It affects quality of life, sleep, work performance and increases healthcare use.
Recent research suggests that the gut microbiome and immune regulation play important roles in allergic diseases. Probiotics may help by balancing gut bacteria and reducing inflammation. Vitamin D, which supports immune function, is often low in people with allergies and may help improve symptoms.
While probiotics and vitamin D have each been studied separately in AR, their combined effect has not been well investigated.
This study aims to evaluate whether combining these supplements with standard care is more effective than using either supplement alone or standard care alone.
This is a randomized, controlled, 2-arm clinical trial. Adult participants with moderate to severe allergic rhinitis will be randomly assigned to one of four groups:
Supplements will be taken for 12 weeks. The study will measure symptom severity, quality of life, and changes in certain immune markers. The findings may offer new insights into effective, low-risk, and accessible options to support allergic rhinitis management.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 120 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 , 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, (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 .
History of diseases or chronic inflammatory conditions.
Sinusitis, otitis media, or respiratory tract infections or upper respiratory infections within 14 days of the study start.
Known 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Standard Allergic Rhinitis Treatment
Dietary Supplement: Combined Vitamin D and Probiotics Supplementation
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
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.
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.
Time frame: From Baseline to Week 12 (End of Intervention)
Change in Serum Immunoglobulin E (IgE) Levels
Total IgE concentration will be measured using ELISA from venous blood samples at baseline and after 12 weeks to assess allergic sensitization and systemic immune response.
Time frame: From Baseline to Week 12
Change in Nasal Eosinophil Count
Nasal smear cytology will be used to quantify eosinophil presence, an indicator of allergic inflammation.
Time frame: From Baseline to Week 12
Change in Serum Interleukin-13 (IL-13) and C-Reactive Protein (CRP)
Serum inflammatory markers IL-13 and CRP will be measured to assess changes in systemic and allergic inflammation.
Time frame: From Baseline to Week 12
Plan to share: Yes
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