Unique ID issued by UMIN | UMIN000033127 |
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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 |
Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease
FMT for Crohn's disease (FEMTRAC) study
Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease
FMT for Crohn's disease (FEMTRAC) study
Japan |
Crohn's disease
Gastroenterology |
Others
YES
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
Others
To study the mechanism of FMT for Crohn's disease
Exploratory
Pragmatic
Phase I,II
Improvement of CDAI score
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
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Maneuver |
fecal microbiota transplatation
normal saline administration
12 | years-old | <= |
80 | years-old | > |
Male and Female
Patients with active Crohn's disease (CDAI 150 or more)
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
50
1st name | |
Middle name | |
Last name | Naoki Ohmiya |
Fujita Health University, Shool of Medicine
Department of Gastroenterology
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
0562-93-9240
nohmiya@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Naoki Ohmiya |
Fujita Health University School of Medicine
Department of Gastroenterology
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
0562-93-9240
nohmiya@fujita-hu.ac.jp
Fujita Health University School of Medicine
Department of Gastroenterology
The Japanese Gastroenterological Association
Non profit foundation
Japan
Shiga University of Medical Science, Kanazawa University, Hyogo College of Medicine Aichi Medical University, Jichi Medical University
none
NO
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)
2018 | Year | 09 | Month | 30 | Day |
Unpublished
before enrollment
Open public recruiting
2018 | Year | 05 | Month | 11 | Day |
2018 | Year | 10 | Month | 01 | Day |
2020 | Year | 03 | Month | 30 | Day |
2020 | Year | 05 | Month | 30 | Day |
2020 | Year | 07 | Month | 31 | Day |
2020 | Year | 09 | Month | 30 | Day |
2018 | Year | 06 | Month | 24 | Day |
2018 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037777
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