Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061920) titled 'A study to evaluate the effects of a multidisciplinary bowel support team for patients after stroke' on June 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Fujita Health University
Condition:
Condition - Bowel functional dysfunction associated with stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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)
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 Size - 240
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068962
Disclaimer: Curated by HT Syndication.