UMIN-CTR Clinical Trial

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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