BridgeMD
New treatment option for Allergic Rhinitis
Official title Effect of Combined Probiotics and Vitamin D on Symptoms of Allergic Rhinitis
ClinicalTrials.gov ID: NCT07115342
What this study is testing
What is Standard Allergic Rhinitis Treatment?
Standard Allergic Rhinitis Treatment is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for allergic rhinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Confirmed diagnosis of AR based on clinical history and specific IgE testing or will be screened for eligibility by the modified Mini...
- 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...
- 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...
You likely can't join if
- Use of systemic corticosteroids, immunosuppressive therapy, or medications affecting the gut microbiota (antimicrobials, probiotics, prebiotics...
- 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...
- Diagnosed with pulmonary tuberculosis, allergic asthma, chronic obstructive pulmonary disease (COPD), mast cell activation syndrome, or other...
- Coexisting conditions such as nasal polyps, severe nasal septum deviation, severe gastrointestinal diseases (e.g., severe diarrhea or inflammatory...
- History of autoimmune diseases or chronic inflammatory conditions.
See the full eligibility 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...
- 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)
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tanta, Gharbia Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tanta, Gharbia Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.