UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034095 |
|---|---|
| Receipt number | R000038491 |
| Scientific Title | Analysis of intestinal bacteria for patients with pancreatic exocrine secretion for precision medicine |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2018/11/04 18:52:07 |
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Basic information
Public title
Analysis of intestinal bacteria for patients with pancreatic exocrine secretion for precision medicine
Acronym
Analysis of intestinal bacteria for patients with pancreatic exocrine secretion for precision medicine
Scientific Title
Analysis of intestinal bacteria for patients with pancreatic exocrine secretion for precision medicine
Scientific Title:Acronym
Analysis of intestinal bacteria for patients with pancreatic exocrine secretion for precision medicine
Region
| Japan |
Condition
Condition
Chronic pancreatitis, autoimmune pancreatitis, postoperative pancreatic, pancreatic exocrine insufficiency
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analysis of intestinal flora with pancreatic exocrine dysfunction or not
Basic objectives2
Others
Basic objectives -Others
Comparison of mucosal micorobiota on digestive tract before and after administration to patients with pancreatic exocrine function disorder
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of mucosal micorobiota on digestive tract with pancreatic exocrine dysfunction or not
Key secondary outcomes
Comparison of mucosal micorobiota on digestive tract before and after administration to patients with pancreatic exocrine function disorder
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
For patients who perform endoscopic ultrasonography for each pancreatic disease at our hospital, aged 20 to 75 years old and consent this study.
Key exclusion criteria
Patients who have progressive disease such as malignant tumor, judged that the doctor inappropriate incorporation into this study, took antibiotics within 4 weeks
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakagami Junichi |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
465 Kajiicho, Kawaramachi-Hirokoji, Kamigyouku, Kyoto
TEL
0752515111
junichi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakagami Junichi |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
465 Kajiicho, Kawaramachi-Hirokoji, Kamigyouku, Kyoto
TEL
0752515111
Homepage URL
junichi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2018 | Year | 12 | Month | 01 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | 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
We take samples from the duodenum by endoscopic ultrasonography for the patients with pancreatic disease and consent to this study. As a collection method, we collect scrape cell fluid on the duodenum by rubbing cytology brush. We collect their feces at the same time.
Management information
Registered date
| 2018 | Year | 09 | Month | 11 | Day |
Last modified on
| 2018 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038491
