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Name:
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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033127
Receipt No. R000037777
Scientific Title Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease
Date of disclosure of the study information 2018/09/30
Last modified on 2018/10/29

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Basic information
Public title Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease
Acronym FMT for Crohn's disease (FEMTRAC) study
Scientific Title Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease
Scientific Title:Acronym FMT for Crohn's disease (FEMTRAC) study
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To study the efficacy of multidonor fecal microbiota transplatation (FMT) for Crohn's disease by the multicenter randomised controlled trial using multidonor fecal microbiota bank in Japan
Basic objectives2 Others
Basic objectives -Others To study the mechanism of FMT for Crohn's disease
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Improvement of CDAI score
Key secondary outcomes 1. IBDQ
2. modified SESCD
3. hydrogen level in glucose hydrogen breath test
4. urine lactulose mannnitol ratio
5. change in fecal microbiome and metabolome

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 fecal microbiota transplatation
Interventions/Control_2 normal saline administration
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
12 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with active Crohn's disease (CDAI 150 or more)
Key exclusion criteria 1. past history of allergy to drugs used in this study
2. possible of documented pregnant women
3. patients with fistula, penetration, and perforation except anal fistula
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University, Shool of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Homepage URL
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Department of Gastroenterology
Institute
Department

Funding Source
Organization The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Shiga University of Medical Science, Kanazawa University, Hyogo College of Medicine Aichi Medical University, Jichi Medical University
Name of secondary funder(s) none

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 藤田保健衛生大学病院(愛知県)、滋賀医科大学(滋賀県)、金沢大学病院(石川県)、兵庫医科大学病院(兵庫県)、自治医科大学病院(栃木県)、愛知医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 30 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
before enrollment
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
2018 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
2020 Year 05 Month 30 Day
Date trial data considered complete
2020 Year 07 Month 31 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 24 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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