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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039406
Receipt No. R000044927
Scientific Title Relationship between intestinal environment and protein-energy malnutrition
Date of disclosure of the study information 2020/02/10
Last modified on 2020/03/16

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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
Email 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
Email rinoue@fhw.oka-pu.ac.jp

Sponsor
Institute Okayama Prefectural University
Institute
Department

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
Email 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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 06 Day
Last modified on
2020 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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