UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060343 |
|---|---|
| Receipt number | R000069027 |
| Scientific Title | Effects of Synbiotic Supplementation on Muscle Health, and Activities of Daily Living in Hospitalized Older Patients with Sarcopenia a randomized controlled trial |
| Date of disclosure of the study information | 2026/01/13 |
| Last modified on | 2026/01/13 22:18:48 |
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Basic information
Public title
Effects of Synbiotic Supplementation on Muscle Health, and Activities of Daily Living in Hospitalized Stroke Patients with Sarcopenia
Acronym
SYN-Musclle Health Study
Scientific Title
Effects of Synbiotic Supplementation on Muscle Health, and Activities of Daily Living in Hospitalized Older Patients with Sarcopenia a randomized controlled trial
Scientific Title:Acronym
SYN-Musclle Health Study
Region
| Japan |
Condition
Condition
Patients with post-stroke sarcopenia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates whether adding synbiotics (Yakult 400W) to standard rehabilitation improves skeletal muscle mass, muscle strength, and ADL in elderly stroke patients with sarcopenia admitted to a recovery-phase rehabilitation ward. It also assesses the feasibility of the intervention to establish a foundation for conducting a future full-scale randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skeletal Muscle Index at the 8-week time point
Key secondary outcomes
Phase angle and other BIVA indicators
Grip strength
FIM motor items
Nutrition-related indicators (GLIM malnutrition, BMI, nutritional intake)
All outcomes will be obtained at the 8-week time point.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention product: Yakult 400W (80mL/once daily)
Intervention period: 8 weeks
Administered orally at breakfast time.
Daily nutritional intake shall be hospital meals tailored to activity levels.
Interventions/Control_2
Control: Milk 100 (100mL/once daily)
Intervention period: 8 weeks
Administered orally at breakfast time.
Daily nutritional intake shall be hospital meals tailored to activity levels.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible cases must meet all of the following criteria:
1) Aged 65 years or older
2) Undergoing rehabilitation following a stroke
3) Sarcopenia according to the Asian Working Group for Sarcopenia 2025 criteria (grip strength: <28 kg for men, <18 kg for women; SMI: <7.0 kg/m2 for men, <5.7 kg/m2 for women)
4) Able to consume food orally (Food Intake Level Scale > 6)
Key exclusion criteria
Exclude subjects meeting any of the following criteria:
1) Acute inflammation or active chronic inflammation within the past 4 weeks
2) Currently receiving antimicrobial therapy
3) Severe renal impairment (eGFR < 15 mL/min/1.73m2)
4) History of allergy to probiotics, prebiotics, or dairy products
5) Subject deemed inappropriate by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yoshimura |
Organization
Kumamoto Rehabilitation Hospital
Division name
Center for sarcopenia and malnutrition research
Zip code
8691106
Address
760 Magatte, Kikuyo Town, Kikuchi District, Kumamoto Prefecture
TEL
0962323111
hanley.belfus@gmail.com
Public contact
Name of contact person
| 1st name | Kouki |
| Middle name | |
| Last name | Yoneda |
Organization
Kumamoto Rehabilitation Hospital
Division name
Department of Nutrition Management
Zip code
8691106
Address
760 Magatte, Kikuyo Town, Kikuchi District, Kumamoto Prefecture
TEL
0962323111
Homepage URL
koukhun@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
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
Kumamoto Rehabilitation Hospital
Address
760 Magatte, Kikuyo Town, Kikuchi District, Kumamoto Prefecture
Tel
0962323111
koukhun@gmail.com
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 | 13 | 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 | 12 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069027
