UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060765 |
|---|---|
| Receipt number | R000069527 |
| Scientific Title | Effects of Barley Porridge Intake on Dysphagia and Gut Microbiota in Hospitalized Elderly Patients |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/02/26 22:36:35 |
* 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
Effects of Barley Porridge Intake on Dysphagia and Gut Microbiota in Hospitalized Elderly Patients
Acronym
Effects on the Gut Microbiota of Hospitalized Elderly Patients
Scientific Title
Effects of Barley Porridge Intake on Dysphagia and Gut Microbiota in Hospitalized Elderly Patients
Scientific Title:Acronym
Effects on the Gut Microbiota of Hospitalized Elderly Patients
Region
| Japan |
Condition
Condition
Elderly with dysphagia and hospitalized elderly
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to conduct a dietary intervention using rice porridge, the staple food for elderly individuals aged 65 and older with dysphagia and hospitalized elderly patients, along with fecal analysis, to verify whether increasing dietary fiber intake can improve the disruption of the gut microbiota in hospitalized elderly patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal microbiota
Key secondary outcomes
Diversity of the Fecal Microbiota
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
White rice porridge
Interventions/Control_2
Waxy barley with white rice porridge
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
Patients aged 65 years or older with a total score of 3 or higher on the Swallowing Disorder Screening Questionnaire (Nestle EAT-10), as well as patients admitted to departments such as orthopedics or cardiology (patients capable of eating for 2 to 4 weeks) will be enrolled as subjects.
Key exclusion criteria
1) Hospitalized patients unable to consume hospital meals continuously for 2 to 4 weeks
2) Hospitalized patients for whom informed consent cannot be obtained from the patient or their authorized representative
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo
TEL
+81-3-5275+6048
s-aoe@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Samban-cho, Chiyoda-ku, Tokyo
TEL
+81-3-5275-6048
Homepage URL
s-aoe@otsuma.ac.jp
Sponsor or person
Institute
Otsuma Women's University, Faculty of Home Economics, Department of Food Science
Institute
Department
Personal name
Funding Source
Organization
Otsuma Women's University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan Health and Medical Corporation Eastern Regional Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science Research Ethics Committee, Otsuma Women's University
Address
12 Samban-cho, Chiyoda-ku, Tokyo
Tel
+81-3-5275-6408
kenkyu.s@ml.otsuma.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
公益財団法人東京都保健医療公社東部地域病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069527
