UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020954 |
|---|---|
| Receipt number | R000023587 |
| Scientific Title | Safety trial of fecal microbiota transplantation for inflammatory bowel disease |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2022/02/15 08:08:10 |
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Basic information
Public title
Safety trial of fecal microbiota transplantation for inflammatory bowel disease
Acronym
Safety trial of fecal microbiota transplantation for IBD
Scientific Title
Safety trial of fecal microbiota transplantation for inflammatory bowel disease
Scientific Title:Acronym
Safety trial of fecal microbiota transplantation for IBD
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate safety of fecal microbiota transplantation for patients of inflammatory bowel disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of fecal microbiota transplantation for inflammatory bowel disease will be assessed in 8 weeks after the treatment according to criteria for adverse events.
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
| Maneuver |
Interventions/Control_1
Fecal microbiota transplantation will be done with colonoscopy on the first day.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Donors must be healthy volunteers over 20 years of age.
Recipients must be patients of ulcerative colitis or Crohn's disease with mild or moderate severity.
Key exclusion criteria
Recipient
1) Severe complications in organs including heart, kidney, lung, hematopoiesis, and coagulation system. Severe infectious disease.
2) HIV infection
3) in breast-feeding
4) in pregnancy
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of gastroenterology
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2235
niken@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Noriho |
| Middle name | |
| Last name | Iida |
Organization
Kanazawa University Hospital
Division name
Department of gastroenterology
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2235
Homepage URL
niida@m-kanazawa.jp
Sponsor or person
Institute
Department of Gastroenterology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Kanazawa University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
0762652000
hpsangak@adm.kanazawa-u.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
| 2016 | Year | 02 | Month | 09 | 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
10
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023587
| 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 |
