UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024633 |
|---|---|
| Receipt number | R000028338 |
| Scientific Title | Examination of the utility of the fecal microbiota transplantation for Crohn's disease |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2018/11/20 21:54:41 |
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Basic information
Public title
Examination of the utility of the fecal microbiota transplantation for Crohn's disease
Acronym
CDFMT
Scientific Title
Examination of the utility of the fecal microbiota transplantation for Crohn's disease
Scientific Title:Acronym
CDFMT
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inflammatory bowel disease does not lead to the identification of the etiology at present, and it is said that the immunoreactive abnormality in the induced gastrointestinal tract is more likely to be associated by a genetic predisposition and an environmental predisposition. In late years it was found that enteric bacteria played an important role in clinical condition of the inflammatory bowel disease. Furthermore, the development of the therapy for the purpose of correcting a change of the intestinal bacterial flora is pushed forward.
As therapy to correct dysbiosis for inflammatory bowel disease, the enteric bacteria transfer (fecal microbiota transplantation: FMT) out of feces attracts attention.
In FMT for the ulcerative colitis, the report of Bennet et al. performed in 1989 becomes the first time. The Borody et al. receive FMT for refractory ulcerative colitis and report it subsequently when remission was obtained in all cases three months later. In reported systematic review, there is a report (9 cohort studies, 8 case reports, 1RCT are included) of 18 FMT treatment and examines a 122 case (79 ulcerative colitis, Crohn's disease 39, unclassifiable four cases) in total recently. In all, which it was 45% of remission rates, and was 36.2% (17.4% - 60.4% of 95% CI) of remission rates by the analysis only for cohort studies.
Whereas, in the cohort study, a lot of reports saying that efficacy of FMT is not found are found.
Which we do when there was no such precedent that the Angelgerger et al. receive FMT for five severe ulcerative colitis from moderate disease, and remission was obtained by 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We examine efficacy of the enteric bacteria transfer out of feces for Crohn's disease in 12 weeks.
Key secondary outcomes
We examine an adverse event and integrity of the enteric bacteria transfer out of feces.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Fecal microbiota transplantation
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Mild to moderate Crohn's disease
(2) We are younger than 65 years old 20 years old or older
(3) One with CDAI (Crohn's disease disease activity index) 450 or less
Key exclusion criteria
(1) Severe Crohn's disease
(2) When there are the serious complications including a stenosis and the abscess which expansion needs and the perianal abscess
(3) When it is developed an infection with the activity
(4) When it is inadequate on the prior examination of the provider (donor) (screening)
(5) When we are given antibiotics two weeks before transplant
(6) When diabetes and hypertension, hyperlipidemia have other serious complications
(7) When we have pregnant possibilities
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Andoh |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Setatsukinowa, Otsu
TEL
077-548-2217
andoh@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Imaeda |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Setatsukinowa, Otsu
TEL
077-548-2217
Homepage URL
http://www.ninai-sums.jp/study/gastrointestinal-medicine
imaeda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
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
滋賀医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 10 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028338
