UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of intestinal bacteria for patients with pancreatic exocrine secretion for precision medicine
Title of the study (Brief title)	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	Sakagami Junichi
Organization	Kyoto Prefectural University of Medicine
Division name	Gastroenterology and Hepatology
Address	465 Kajiicho, Kawaramachi-Hirokoji, Kamigyouku, Kyoto
TEL	0752515111
Email	junichi@koto.kpu-m.ac.jp

Public contact
Name of contact person	Sakagami Junichi
Organization	Kyoto Prefectural University of Medicine
Division name	Gastroenterology and Hepatology
Address	465 Kajiicho, Kawaramachi-Hirokoji, Kamigyouku, Kyoto
TEL	0752515111
Homepage URL
Email	junichi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038491