UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020327 |
|---|---|
| Receipt number | 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 20:46:38 |
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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
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
nagayama@jichi.ac.jp
Sponsor or person
Institute
Department of Medicine, Division of Gastroenterology, Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
