Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)
Conditions
Interventions
Synbiotic supplementation (Synprotec, Yakult Honsha Co., Ltd.) will be administered twice daily (morning and evening) via a nasogastric tube. The intervention will be continued during the patient'
s stay in the stroke care unit, for up to a maximum of 14 days.
Sponsors
Tokushima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients diagnosed with acute severe stroke (ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage) with a National Institutes of Health Stroke Scale (NIHSS) score of >=15 who are admitted to our stroke care unit and initiated on enteral nutrition via a nasogastric tube.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding individuals Patients with conditions that preclude enteral nutrition (e.g., bowel obstruction, gastrointestinal perforation) Patients who have been regularly using synbiotic products prior to study initiation Patients with a known allergy or hypersensitivity to synbiotic products Patients (or their legal representatives) who decline participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Enteral Feeding Intolerance (EFI) free days ratio during the 14 days after enrollment, calculated as EFI-free days divided by the number of intervention days. For each study day, a value of 1 is assigned if none of the EFI criteria are met, and 0 if any of the EFI criteria are met. The ratio ranges from 0 to 1, with values closer to 1 indicating better tolerance and values closer to 0 indicating poorer tolerance. EFI is defined as the presence of any of the following conditions: 1. Increased gastric residual volume (GRV): GRV >=100 mL on two consecutive measurements, or >=200 mL on a single measurement, accompanied by physician-directed reduction or interruption of enteral nutrition. 2. Vomiting or aspiration: Interruption of enteral nutrition due to vomiting, or interruption based on clinical suspicion of aspiration. 3. Abdominal distension or pain: Reduction of enteral nutrition by at least half, or temporary cessation, based on clinical judgment of abdominal distension or pain. 4. Diarrhea: Bristol Stool Scale type 6-7 occurring >=3 times in one day and requiring therapeutic intervention such as administration of probiotics/antidiarrheal agents, formula modification, or increased fluid supplementation. 5. Constipation: No bowel movement for >=72 hours requiring intervention (e.g., laxatives, manual disimpaction), or reduction/interruption of enteral feeding due to defecation difficulty. 6. Therapeutic intervention for intolerance: New initiation or dose increase of gastrointestinal motility agents, or switching to a lower-osmolar or semi-elemental formula due to suspected intolerance. | — |
Countries
Japan
Contacts
Public ContactSaki Saijo
Tokushima University Graduate School Department of Emergency and Critical Care Medicine, Institute of Biomedical Sciences
Outcome results
None listed