UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040326 |
|---|---|
| Receipt number | 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 21:27:22 |
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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
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
k-tominaga@med.niigata-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046013
| 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 |
