Efficacy and Safety of Dietary Fiber in Patients with Acute Ischemic Stroke
- Conditions
- Acute ischemic strokeAcute ischemic stroke, enteral nutrition, short-chain fatty acidsD000083242
- Registration Number
- JPRN-jRCTs031230208
- Lead Sponsor
- Kurita Naohide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of diarrhea as defined by the Bristol stool scale from the start of enteral nutrition administration to the end of the observation period (day 14) (total number of days with diarrhea for all subjects/total number of observation days for all subjects)
- Secondary Outcome Measures
Name Time Method umber of days of diarrhea from the start of enteral nutrition to the 14th day<br>Number of days of vomiting from the start of enteral feedings to the 14th day<br>Change in stool short-chain fatty acid concentration from baseline (before enteral nutrition) to day 14 of <br> administration<br>NIHSS (baseline, 7 days, 14 days)<br>Modified Rankin Scale (baseline, 14 days, 90 days)<br>Gut microbiota (baseline, 14 days)<br>Nutritional status (Geriatric Nutritional Risk Index, CONUT score) (baseline, 14 days, 90 days)<br>Nutrition and inflammation-related markers (albumin, pre albumin, retinol-binding protein, high-sensitivity- <br> CRP, interleukin 6, LPS, LPS-binding protein) (baseline, 14 days)