UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031920
Receipt No. R000035761
Scientific Title Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day)
Date of disclosure of the study information 2018/03/31
Last modified on 2019/01/18

* 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 Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day)
Acronym Evaluation of half-ED
Scientific Title Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day)
Scientific Title:Acronym Evaluation of half-ED
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the change of intestinal flora by healthy persons with Half-ED (900 kcal / day) for 2 weeks, and aim to acquire basic data for elucidating the mechanism of action of nutritional therapy and develop it into the next research.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of intestinal flora change by combining analysis results below.
1) fecal analysis (collected at 2, 4, 6 week)
16S metagenomic analysis, metabolome analysis
2) Blood biochemistry (collected at 2, 4, 6 weeks)
nutritional indicators (ALB, TP, TC), amino acids, fatty acids
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 1) Dietary guidance period (2 weeks)
Provide meal guidance by meal instruction instructor.
2) Half-ED period (2 weeks)
Reduce normal meal volume to about half and administer ED 900 kcal/day.
3) Normal diet period (2 weeks)
Return to normal meal intake.
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Healthy person
Key exclusion criteria Exclusion criteria are shown below.
1) Person with history of IBD
2) Person who underwent laparotomy surgery within half a year from the start of the study
3) Person with taking antibiotics within half a year of start the study
4) Major drinkers
5) Person with regularly taking medications
6) Person who can not refrain from intake of foods, supplements, medicines that affect the intestinal environment during the test period
7) Person with metabolism abnormality such as diabetes
8) Person with amino acid metabolic abnormality
9) Person with history of hypersensitivity to the study drug
10) Person with pregnancy / breast-feeding
11) Person who plans to change life style significantly during the examination period
12) Person who has chronic diarrhea easily
13) Person who participated in other clinical trials within the past 3 months
14) Person who can not obtain consent of participation in this clinical study
15) Person who is judged by study responsible doctor as inappropriate as subject
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadakazu Hisamatsu
Organization Kyorin University School of Medicine
Division name The Third Department of Internal Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL +81-422-47-5511
Email thisamatsu@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Saito
Organization Kyorin University School of Medicine
Division name The Third Department of Internal Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL +81-422-47-5511
Homepage URL
Email straw@zb3.so-net.ne.jp

Sponsor
Institute Kyorin University School of Medicine
Institute
Department

Funding Source
Organization EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 Month 31 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 Completed
Date of protocol fixation
2018 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 31 Day
Last follow-up date
2019 Year 01 Month 18 Day
Date of closure to data entry
2019 Year 01 Month 18 Day
Date trial data considered complete
2019 Year 01 Month 18 Day
Date analysis concluded
2019 Year 01 Month 18 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2019 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.