UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056612 |
|---|---|
| Receipt number | R000063857 |
| Scientific Title | The effect of gut microbiota on malnutrition and sarcopenia in early stroke patients |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/01/02 01:09:23 |
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Basic information
Public title
The effect of gut microbiota on malnutrition and sarcopenia in early stroke patients
Acronym
The effect of gut microbiota on malnutrition and sarcopenia in early stroke patients
Scientific Title
The effect of gut microbiota on malnutrition and sarcopenia in early stroke patients
Scientific Title:Acronym
The effect of gut microbiota on malnutrition and sarcopenia in early stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on abnormalities in the gut microbiota (intestinal flora) as a visible indicator of changes in intestinal function associated with systemic inflammation. We hypothesized that intestinal dysfunction caused by systemic inflammation following stroke promotes abnormalities in the gut microbiota, leading to the development of malnutrition and, subsequently, sarcopenia. By verifying this hypothesis and elucidating the impact of temporal changes in the gut microbiota on malnutrition and sarcopenia, we aim to develop treatment strategies to prevent the complication of sarcopenia following stroke. This forms the basis of our research plan.
Basic objectives2
Others
Basic objectives -Others
In previous studies, we identified malnutrition as the most influential risk factor for sarcopenia during the early stages of stroke onset. This is attributed to several factors: stroke-induced brain cell death often triggers systemic inflammation; in cases where patients experience consciousness disorders or dysphagia secondary to stroke, fasting periods immediately after onset may lead to apoptosis in the intestinal mucosa, resulting in mucosal atrophy; and the predominance of sympathetic nervous system activity suppresses intestinal motility, making digestive and absorption disorders such as diarrhea and constipation more likely. These factors collectively predispose patients to malnutrition.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metagenomic analysis information of gut microbiota
Key secondary outcomes
Body composition (body mass index, skeletal muscle mass, skeletal muscle index, muscle quality, body fat mass, etc.), grip strength on the non-paralyzed side, severity of dysphagia (Food Intake LEVEL Scale), Functional Independence Measure (FIM), dietary texture, dietary intake, nutritional risk indicators, and diagnostic results for malnutrition and sarcopenia (or obesity)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who can provide written consent for research participation based on their free will.
Key exclusion criteria
Female patients who are pregnant or may be pregnant, patients with a cardiac pacemaker, patients with severe dementia, patients with foreign nationalities other than Japanese, and cases deemed inappropriate by the attending physician.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | MOMOKO |
| Middle name | |
| Last name | SAKURAI |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-dori, Hirokoji-agaru, Kamigyo-ku, Kyoto-shi, Kyoto, Japan.
TEL
09070922198
momoima@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | MOMOKO |
| Middle name | |
| Last name | SAKURAI |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-dori, Hirokoji-agaru, Kamigyo-ku, Kyoto-shi, Kyoto, Japan.
TEL
09070922198
Homepage URL
momoima@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
SAKURAI MOMOKO
Funding Source
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-dori, Hirokoji-agaru, Kamigyo-ku, Kyoto-shi, Kyoto, Japan.
Tel
09070922198
momoima@koto.kpu-m.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 | 04 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic Patient Information: Age, gender, height, weight, diagnosis, affected side, date of onset, date of admission, date of discharge, medical history.
Primary Evaluation Item: Fecal samples will be collected at the time of admission and discharge from acute care hospitals and rehabilitation hospitals for evaluation.
Secondary Evaluation Item: Medical records will be extracted at the time of admission and discharge from acute care hospitals and rehabilitation hospitals.
Management information
Registered date
| 2025 | Year | 01 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063857
