Immune Benefits of WGP in Elderly (NCT02262091) | Clinical Trial Compass
CompletedNot Applicable
Immune Benefits of WGP in Elderly
Germany150 participantsStarted 2014-08
Plain-language summary
The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.
Who can participate
Age range
70 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:
* Male and female elderly volunteers equal or above age of 70
* Pre-frail and frail subjects (based on Fried's criteria)
* Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
* Having obtained his/her (or his/her legal representative's) informed consent
Exclusion Criteria:
* Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
* Allergy to eggs or influenza vaccine components.
* Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
* Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
* Subject who has taken antibiotics in the last 2 months prior to entering the study.
* Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements.
* Personal or family history of Guillain-Barre syndrome
* BMI\>35 kg/m2
* Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study.
* Subject who cannot be expected to comply with the study procedures
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this 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
Change from baseline at 4 weeks post-vaccination in antibody titers levels