UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the influence of microbiota on digestive system diseases
Acronym	Study of microbiota and digestive system diseases
Scientific Title	Analysis of the influence of microbiota on digestive system diseases
Scientific Title:Acronym	Study of microbiota and digestive system diseases
Region	Japan

Condition
Condition	Small intestinal Crohn's disease, the other small intestinal diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the characteristics of the small intestinal microbiota of Crohn's disease and other digestive system diseases
Basic objectives2	Others
Basic objectives -Others	To clarify the influences of small intestinal microbiota derived from the patients on the murine intestinal immune system
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Data of the bacterial 16S rRNA by next-generation sequencer
Key secondary outcomes	Data of the intestinal immune cells by flow cytometry (animal experiments)

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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	During the registration period from May 12, 2015, to March 31, 2023, the patients undergo a maximum of six intestinal mucosal biopsies, mucosal scrapes, and aspiration of intestinal juice at the double-balloon endoscopic examination.
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	Patients with small intestinal Crohn's disease or the other small intestinal diseases requiring double-balloon endoscopy with written informed consent
Key exclusion criteria	Patients under poor conditions as follows: acute abdomen, ileus, bowel perforation, pancreatitis, respiratory disease, heart disease, hemophilia, patients with too large intestinal ulcers or tumors Patients with acute severe inflammation Patients with abnormal coagulopathy Pregnant patients or patients during breast feeding Contraindication of bowel cleansing agent Patients who are considered inappropriate
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hironori Middle name Last name Yamamoto
Organization	Jichi Medical University
Division name	Department of Medicine, Division of Gastroenterology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7348
Email	ireef@jichi.ac.jp

Public contact
Name of contact person	1st name Manabu Middle name Last name Nagayama
Organization	Jichi Medical University
Division name	Department of Medicine, Division of Gastroenterology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7348
Homepage URL
Email	nagayama@jichi.ac.jp

Sponsor
Institute	Department of Medicine, Division of Gastroenterology, Jichi Medical University
Institute
Department

Funding Source
Organization	Department of Medicine, Division of Gastroenterology, Jichi Medical University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Jichi Medical University
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
Tel	0285-58-7550
Email	rinri@jichi.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	2015 Year 12 Month 24 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	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 12 Day
Date of IRB	2015 Year 05 Month 12 Day
Anticipated trial start date	2015 Year 05 Month 12 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 12 Month 24 Day
Last modified on	2020 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023454