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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024633
Receipt No. 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

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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
Email 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
Email imaeda@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028338

Research Plan
Registered date File name
2017/01/12 03-1_人を対象とする医学系研究計画書の様式_ver2.2(CDFMT_UMIN000024633)PDF.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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