A multicenter, randomized, open-label, drug-controlled, parallel-group study to evaluate the efficacy and safety of enteral nutrition containing highly fermentable dietary fiber in patients with acute ischemic stroke

Kurita Naohide0 个研究点目标入组 38 人开始时间: 2023年7月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients who are 20 years of age or older at the time consent is obtained
•2) Patients admitted with a diagnosis of acute ischemic stroke within 48 hours of onset
•3) Patients with acute ischemic stroke confirmed by head MRI diffusion-weighted imaging
•4) Patients with dysphagia who require enteral nutrition
•5)Patients who have the capacity to consent and are able to obtain the written consent of their own free will or patients who have difficulty in obtaining written consent due to impaired consciousness or other reasons. If the patient is unable to give consent due to impaired consciousness or other reasons, the patient must be able to obtain written consent from a surrogate (20 years of age or older, within the second degree of kinship).
•(6) Patients who are judged by the principal investigator (sub-investigator) to be capable of adequately evaluating the efficacy and safety of the study, taking into consideration the selection and exclusion criteria.

•1) Patients with pneumonia or other infectious diseases for which enteral nutrition is inappropriate
•2) Patients with severe renal disease (serum creatinine level > 2.0 mg/dL)
•3) Patients with serious hepatic disorder (AST or ALT > 100 U/L)
•4) Patients with serious cardiac disease
•5) Patients with milk allergy (allergy to milk protein and whey)
•6) Patients with diarrhea of any kind
•7) Other patients deemed inappropriate as research subjects by the principal investigator (or sub-investigator)

发起方

Kurita Naohide