Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-patholog… (NCT06726486) | Clinical Trial Compass
CompletedPhase 4
Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores
Spain69 participantsStarted 2022-01-01
Plain-language summary
The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients.
Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.
Who can participate
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:
* Hospitalized chronic patients with complex needs in the Internal Medicine Department of a regional hospital.
* Malnourished or at risk of malnutrition.
* Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.
Exclusion Criteria:
* Limitations in oral intake (due to pathologies, state of health, among others).
* Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.
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.