UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033127
Receipt number 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 02:48:11

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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 or person

Institute

Fujita Health University School of Medicine
Department of Gastroenterology

Institute

Department

Personal name



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

Value
https://center6.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