JPRN-jRCTs031230208
Recruiting
未知
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 sites38 target enrollmentJuly 6, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Acute ischemic stroke
- Sponsor
- Kurita Naohide
- Enrollment
- 38
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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)
Outcomes
Primary Outcomes
Not specified
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