Efficacy and Safety of Dietary Fiber in Patients with Acute Ischemic Stroke

JRCT ID: jRCTs031230208

Registered date:06/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute ischemic stroke
• Date of first enrollment: 06/07/2023
• Target sample size: 38
• Study type: Interventional
• Intervention(s): Peptaemen Previo or Ensure H should be started within 72 hours of admission and administered three times daily for 14 days.

Outcome(s)

• Primary Outcome: 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

Number of days of diarrhea from the start of enteral nutrition to the 14th day
Number of days of vomiting from the start of enteral feedings to the 14th day
Change in stool short-chain fatty acid concentration from baseline (before enteral nutrition) to day 14 of
administration
NIHSS (baseline, 7 days, 14 days)
Modified Rankin Scale (baseline, 14 days, 90 days)
Gut microbiota (baseline, 14 days)
Nutritional status (Geriatric Nutritional Risk Index, CONUT score) (baseline, 14 days, 90 days)
Nutrition and inflammation-related markers (albumin, pre albumin, retinol-binding protein, high-sensitivity-
CRP, interleukin 6, LPS, LPS-binding protein) (baseline, 14 days)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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)

Related Information

• Primary Sponsor: Yamashiro Kazuo
• Source(s) of Monetary Support: Nestle Japan Limited