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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020327
Receipt No. R000023454
Scientific Title Analysis of the influence of microbiota on digestive system diseases
Date of disclosure of the study information 2015/12/24
Last modified on 2020/12/30

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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/ctr_e/ctr_view.cgi?recptno=R000023454

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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