UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020136 |
|---|---|
| Receipt number | R000023249 |
| Scientific Title | Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection. |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2016/02/03 17:22:10 |
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Basic information
Public title
Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Acronym
FMT for IBD and CDI
Scientific Title
Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Scientific Title:Acronym
FMT for IBD and CDI
Region
| Japan |
Condition
Condition
ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the safety, usefulness, and compliance of FMT for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse events of FMT, change of activity scores of patients with IBD and symptoms of patients with CDI by FMT
Key secondary outcomes
Change of gut microbiota by FMT
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)CDI
recurrent or refractory CDI by vancomycin
2)IBD
IBD not responded by conventional therapy including 5ASA, corticosteroid, and biologics
Key exclusion criteria
(1)Recipient
1)Allergy to drugs used in FMT
2)Pregnant or possible pregnant
3)Judged as unsuitable by researchers
(2)Donor
1)Malignancy, active or choronic infection
2)pregnant
3)3)Judged as unsuitable by researchers
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho
TEL
0562-93-9240
nohmiya@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho
TEL
0562-93-9240
Homepage URL
shokakan@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
藤田保健衛生大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective cohort study of patietns enrolled from Dec 9,2015 to Dec 31, 2022.Recipient's clinical symptoms, fecal microbiota, C.difficile toxins, ribotyping, blood analysis, endoscopic findings, enterocolonographic findigns, CT findings, depression score, BMI. Donor's fecal microbiota, CD toxins, ribotyping,blood analysis, endoscopic findings, enterocolonographic findigns, CT findings, depression score, BMI.
Management information
Registered date
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023249
