UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061920 |
|---|---|
| Receipt number | R000068962 |
| Scientific Title | Effectiveness of a Multidisciplinary Bowel Support Team for Bowel Dysfunction in Stroke Patients: A Stepped Wedge Cluster Randomized Trial |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 22:16:42 |
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Basic information
Public title
A study to evaluate the effects of a multidisciplinary bowel support team for patients after stroke
Acronym
STROKE-BOWEL Study
Scientific Title
Effectiveness of a Multidisciplinary Bowel Support Team for Bowel Dysfunction in Stroke Patients: A Stepped Wedge Cluster Randomized Trial
Scientific Title:Acronym
SW-CRT
Region
| Japan |
Condition
Condition
Bowel functional dysfunction associated with stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a multidisciplinary bowel support team intervention on bowel function in patients with bowel functional dysfunction associated with stroke.
Basic objectives2
Others
Basic objectives -Others
To clarify the effects of a bowel support team intervention on quality of life (QOL), bowel care practices, and medication use in patients with stroke.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of normal stools (Bristol Stool Form Scale types 3-5) per week
Key secondary outcomes
Quality of life assessed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Comprehensive bowel care intervention by a multidisciplinary bowel support team
A multidisciplinary bowel support team, consisting of physicians, nurses, physical therapists, occupational therapists, pharmacists, and dietitians, provides comprehensive bowel care for hospitalized patients with bowel functional dysfunction associated with stroke.
The intervention is conducted for 4 weeks, during which the following components are continuously implemented:
Daily recording of bowel habits using a bowel diary
Assessment of bowel function using abdominal ultrasound (iViz air), approximately once per week as needed
Guidance on defecation posture and toilet environment
Nutritional guidance regarding meals and fluid intake
Rehabilitation interventions to promote bowel motility
Review and optimization of the use of existing laxatives and constipation-related medications
Interventions/Control_2
Usual bowel care (control)
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
Hospitalized patients with stroke admitted to Fujita Health University Nanakuri Memorial Hospital
Patients with bowel functional dysfunction associated with stroke who are receiving bowel care
Written informed consent obtained from the patient or a legally authorized representative
Key exclusion criteria
Patients with a history of organic bowel disease
Patients at risk of colorectal bleeding
Patients receiving nutrition exclusively via parenteral nutrition
Patients who do not wish to modify their bowel care
Patients deemed inappropriate for participation by the investigators
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Sugama |
Organization
Fujita Health University
Division name
Center for Social Implementation Nursing Science
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2506
ishikame@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ishikame |
Organization
Fujita Health University
Division name
School of Health Sciences, Department of Nursing
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2506
Homepage URL
ishikame@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
Tel
0562-93-2315
rinri@fujita-hu.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 | 06 | Month | 15 | 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
73
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
Completed
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068962
