UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044910 |
|---|---|
| Receipt number | R000051291 |
| Scientific Title | Study on the relationship between gastrointestinal microflora and gastrointestinal metabolic diseases |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2024/03/28 19:15:57 |
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Basic information
Public title
Study on the relationship between gastrointestinal microflora and gastrointestinal metabolic diseases
Acronym
Evaluation of the relationship between gastrointestinal microbiota and gastrointestinal metabolic diseases
Scientific Title
Study on the relationship between gastrointestinal microflora and gastrointestinal metabolic diseases
Scientific Title:Acronym
Evaluation of the relationship between gastrointestinal microbiota and gastrointestinal metabolic diseases
Region
| Japan |
Condition
Condition
Metabolic Diseases Related to Gastrointestinal Diseases
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between gastrointestinal microbiota and systemic diseases such as gastrointestinal metabolic diseases and psychiatric diseases.
Basic objectives2
Others
Basic objectives -Others
Relationship between gastrointestinal microbiota and drugs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between gastrointestinal microbiota and gastrointestinal metabolic diseases
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients undergoing upper or lower gastrointestinal endoscopy
(2) Patients who fully understand this research plan and are able to give their consent.
(3) Patients who are 20 years of age or older at the time of obtaining consent.
Key exclusion criteria
Patients who are deemed unsuitable by the attending physician or researcher
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Eikichi |
| Middle name | |
| Last name | Ihara |
Organization
Kyushu University
Division name
Department of gastroenterolgy and metabolism
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+81926425286
eikichi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Minoda |
Organization
Kyushu university
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+81926425286
Homepage URL
minoda.yosuke.633@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu 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
Kyushu university
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
0926425082
byskenkyu@jimu.kyushu-u.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
| 2021 | Year | 07 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of gastrointestinal microbiota and gastrointestinal metabolic diseases
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051291
