Dietary Supplement (Beta-Glucans) in Allergic Patients Undergoing Subcutaneous Immunotherapy.
Spain60 participantsStarted 2024-05-29
Plain-language summary
The present study will attempt to determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol. It will also attempt to determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 65 years.
* Both sexes.
* Patients diagnosed with allergic rhinitis or allergic rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing treatment with subcutaneous polymerized 100 immunotherapy, initiating treatment with rapid dosing.
* Normoglycemia (fasting glucose ≤ 100 mg/dL).
* BMI between 18.5-29.9 kg/m².
Exclusion Criteria:
* Refusal to sign the informed consent.
* Outside the age range specified for the study.
* Presence of intolerance or hypersensitivity to selenium or zinc, or to any of the components of the dietary supplement individually.
* Participation in a clinical trial within the past two months, or currently participating in another study.
* Personal history of liver or kidney disease.
* Excessive alcohol consumption (\> 20 grams/day) or use of substance abuse.
* Any condition that, in the opinion of the investigators, renders the subject unable to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness of the dietary supplement
Timeframe: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.