UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016351 |
|---|---|
| Receipt number | R000018983 |
| Scientific Title | Integrated analysis of oral, gastric, intestinal and fecal microbiota and metabolome for diverse digestive disorders |
| Date of disclosure of the study information | 2015/01/27 |
| Last modified on | 2015/01/27 15:29:12 |
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Basic information
Public title
Integrated analysis of oral, gastric, intestinal and fecal microbiota and metabolome for diverse digestive disorders
Acronym
Integrated analysis of microbiota in diverse digestive disorders
Scientific Title
Integrated analysis of oral, gastric, intestinal and fecal microbiota and metabolome for diverse digestive disorders
Scientific Title:Acronym
Integrated analysis of microbiota in diverse digestive disorders
Region
| Japan |
Condition
Condition
inflammatory bowel disease, radiation induced gastrointestinal injury, esophagitis, achalasia, Helicobacter pylori-related disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore relationship between oral, gastric, intestinal and fecal 16s rRNA-based microbita and metabolome (oraganic acids, bile acids) in diverse digestive diseases
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyses of oral, gastric, intestinal and fecal 16s rRNA-based microbita in diverse digestive 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
inflammatory bowel diseases, radiation induced gastrointestinal injury, reflux esophagitis, Helicobacter pylori-related idseases, achalasia
Key exclusion criteria
antibiotics administration during past 4 weeks
surgical intervention
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
hajimei2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
Homepage URL
hajimei2002@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
agasaki University Hospital, Endoscopy
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
Address
Tel
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
| 2015 | Year | 01 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study may contribute to pathogenesis and new treatment strategy in diverse digestive disorders via metagenomic and metabolome analyses
Management information
Registered date
| 2015 | Year | 01 | Month | 27 | Day |
Last modified on
| 2015 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018983
