UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039406 |
|---|---|
| Receipt number | R000044927 |
| Scientific Title | Relationship between intestinal environment and protein-energy malnutrition |
| Date of disclosure of the study information | 2020/02/10 |
| Last modified on | 2021/08/13 17:15:45 |
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Basic information
Public title
Relationship between intestinal environment and protein-energy malnutrition
Acronym
Relationship between intestinal environment and protein-energy malnutrition
Scientific Title
Relationship between intestinal environment and protein-energy malnutrition
Scientific Title:Acronym
Relationship between intestinal environment and protein-energy malnutrition
Region
| Japan |
Condition
Condition
Relief of constipation
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the elimination of the dynamics and the constipation of the intestinal bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reveal the dynamics of the intestinal bacterial flora in the melted-rice amazake. The intake period is six weeks and the amount is 35g per day.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The amount of 35g per day of melted-rice amazake for six weeks
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who have obtained consent to the purpose of the research
Key exclusion criteria
1. Patients with terminal cancer who may not be expected to be discharged
2. Other cases judged by the representative to be incompatible for conducting this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Irie |
Organization
Okayama Prefectural University
Division name
Department of Nutrition Sciences
Zip code
719-1197
Address
111 Kuboki, Soja-city, Okayama
TEL
0866-94-2111
yirie@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Rikako |
| Middle name | |
| Last name | Inoue |
Organization
Okayama Prefectural University
Division name
Department of Nutrition Sciences
Zip code
719-1197
Address
111 Kuboki, Soja-city, Okayama
TEL
0866-94-2111
Homepage URL
rinoue@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Okayama Prefectural University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University
Address
111 Kuboki, Soja-city, Okayama
Tel
0866-94-2111
rinoue@fhw.oka-pu.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
| 2020 | Year | 02 | Month | 10 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044927
