Allergic RhinitisNCT07115342
Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis
A study testing Standard Allergic Rhinitis Treatment and Combined Vitamin D and Probiotics Supplementation in people with Allergic Rhinitis and Allergic Rhinitis (AR), run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinitis (AR)
- What is being tested?
- Standard Allergic Rhinitis Treatment and Combined Vitamin D and Probiotics Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital, ENT Department
Tanta, Gharbia Governorate
Prof. Medhat Mohammed Heshmat Mansour Professor of Otolaryngology, Tanta University, 0020-40 3351 398, medhatmansour@hotmail.com
About this study
Official title: Investigating Efficacy of Combined Probiotics and Vitamin D Supplementation in Reducing Symptoms and Improving Quality of Life in Patients With Allergic Rhinitis
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:
Read more
- 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.
Read the detailed description
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:
- Standard care (control group)
- Standard care + probiotics + vitamin D
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.
- Conditions
- Allergic Rhinitis, Allergic Rhinitis (AR)
- Being tested
- Standard Allergic Rhinitis Treatment, Combined Vitamin D and Probiotics Supplementation
- 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
- Medical subject headings
- Rhinitis, Allergic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Allergic Rhinitis TreatmentDrug
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 SupplementationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Not described Receives: Drug: Standard Allergic Rhinitis Treatment |
| Combination Group | Experimental | Not described Receives: Dietary Supplement: Combined Vitamin D and Probiotics Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Week 12 (End of Intervention)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Aug 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ashraf Ahmed Abdel Hadi, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115342
- Sponsor's protocol ID
- 36264MS944/5/25
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Efficacy of Combined Probiotics and Vitamin D Supplementation in Reducing Symptoms and Improving Quality of Life in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07115342
- Acronym / sponsor ID
- 36264MS944/5/25
- Conditions
- Allergic Rhinitis, Allergic Rhinitis (AR)
- Keywords
- Nutritional Supplementation, Integrative Medicine, Vitamin D Deficiency, T Regulatory Cells, Th2 Inflammation, Immune Response, Anti-inflammatory, Lactobacillus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Standard care (control group)
- Standard care + probiotics + vitamin D
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: Standard Allergic Rhinitis Treatment |
| Combination Group | Experimental | Dietary Supplement: Combined Vitamin D and Probiotics Supplementation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Allergic Rhinitis TreatmentParticipants 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 | Drug | Control Group |
| Combined Vitamin D and Probiotics SupplementationParticipants 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. | Dietary supplement | Combination Group |
Primary outcome
Change in Total Nasal Symptom Score (TNSS) and Quality of Life in Patients With Allergic Rhinitis
Time frame: 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.
3 secondary outcomes
Change in Serum Immunoglobulin E (IgE) Levels
Time frame: From Baseline to Week 12
Change in Nasal Eosinophil Count
Time frame: From Baseline to Week 12
Change in Serum Interleukin-13 (IL-13) and C-Reactive Protein (CRP)
Time frame: From Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Allergic Rhinitis Treatment and Combined Vitamin D and Probiotics Supplementation in people with Allergic Rhinitis and Allergic Rhinitis (AR), run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Nasal Symptom Score (TNSS) and Quality of Life in Patients With Allergic Rhinitis (time frame: From Baseline to Week 12 (End of Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.