UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059733 |
|---|---|
| Receipt number | R000068293 |
| Scientific Title | Before-after Intervention Study of Synbiotic Supplementation for Improving Gastrointestinal Symptoms in Acute Severe Stroke Patients |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/11/11 08:19:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of Synbiotic Supplementation for Improving Gastrointestinal Symptoms in Patients With Severe Stroke
Acronym
Stroke x Synbiotics Study
Scientific Title
Before-after Intervention Study of Synbiotic Supplementation for Improving Gastrointestinal Symptoms in Acute Severe Stroke Patients
Scientific Title:Acronym
Stroke x Synbiotics Study
Region
| Japan |
Condition
Condition
Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)
Classification by specialty
| Neurosurgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of synbiotic supplementation on gastrointestinal symptoms, including gastric residual volume, constipation, and diarrhea, in patients with acute severe stroke receiving enteral nutrition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Saki |
| Middle name | |
| Last name | Saijo |
Organization
Tokushima University Graduate School
Division name
Department of Emergency and Critical Care Medicine, Institute of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-9347
saki.saijo@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Saijo |
Organization
Tokushima University Graduate School
Division name
Department of Emergency and Critical Care Medicine, Institute of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-9347
Homepage URL
saki.saijo@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Kojinkai
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
Tel
088-615-8512
first-ec@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068293
