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

NCT ID: NCT07115342

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-11-30

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Group Type: EXPERIMENTAL

Standard Allergic Rhinitis Treatment

Intervention Type: 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

Combination Group

Group Type: EXPERIMENTAL

Combined Vitamin D and Probiotics Supplementation

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ashraf Ahmed Abdel Hadi

Demonstrator, Clinical Pharmacy Department, Badr University in Cairo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospital, ENT Department

Tanta, Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Prof. Medhat Mohammed Heshmat Mansour Professor of Otolaryngology, Tanta University

Role: primary

medhatmansour@hotmail.com

0020-40 3351 398

Other Identifiers

36264MS944/5/25

Identifier Type: -

Identifier Source: org_study_id