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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000040326
Receipt No. R000046013
Scientific Title Elucidation of the pathogenesis of diversion colitis and the usefulness of autologous fecal microbiota
Date of disclosure of the study information 2020/05/07
Last modified on 2020/05/07

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Basic information
Public title Elucidation of the pathogenesis of diversion colitis and the usefulness of autologous fecal microbiota transplantation
Acronym Elucidation of the pathogenesis of diversion colitis and the usefulness of autologous fecal microbiota
Scientific Title Elucidation of the pathogenesis of diversion colitis and the usefulness of autologous fecal microbiota
Scientific Title:Acronym Elucidation of the pathogenesis of diversion colitis and the usefulness of autologous fecal microbiota
Region
Japan

Condition
Condition Diversion colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the status of intestinal microbiota in diversion colitis.
To elucidate the effect of autologous fecal microbiota transplantation through microbiota and short chain fatty acid and to develop the new treatment of diversion colitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Elucidate the diverted colon by endoscopy and the change of microbiota 4 weeks after fecal transplantation.
Key secondary outcomes

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 Treatment
Type of intervention
Other
Interventions/Control_1 We injected 30-50 mL of saline-diluted autologous feces from the stoma to the diverted colon using a Nelaton catheter; 10 FMTs were performed over 4 weeks (every 3 days)
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1)10 patients who were diagnosed as diversion colitistis in our gastroenterology department after colorectal surgery associated with colorectal cancer or inflammatory bowel disease. The participation is based on the patient's free will.
(2) Patients who fully understand this study and can obtain their consent.
(3) Patients aged 20 years or older at the time of obtaining consent.
Key exclusion criteria (1) Patients under the age of 20.
(2) Pregnant women or nursing patients.
(3) Patients within 1 month after bowel surgery.
(4) Patients whom doctors deem inappropriate.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shuji
Middle name
Last name Terai
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Division of Gastroenterology and Hepatology
Zip code 9518510
Address 1-757, Asahimachi-dori, Chuo-ku
TEL 0252272207
Email terais@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Tominaga
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Division of Gastroenterology and Hepatology
Zip code 9518510
Address 1-757, Asahimachi-dori, Chuo-ku
TEL 0252272207
Homepage URL
Email k-tominaga@med.niigata-u.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department

Funding Source
Organization Ministry of Education, Science, Technology, Sports.
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 Graduate School of Medical and Dental Sciences, Niigata University
Address 1-757, Asahimachi-dori, Chuo-ku
Tel 0252272625
Email niigata@esct.bvits.com

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
2020 Year 05 Month 07 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 Suspended
Date of protocol fixation
2018 Year 01 Month 06 Day
Date of IRB
2018 Year 02 Month 02 Day
Anticipated trial start date
2018 Year 02 Month 06 Day
Last follow-up date
2020 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
2020 Year 05 Month 07 Day
Last modified on
2020 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046013

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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