Unique ID issued by UMIN | UMIN000021126 |
---|---|
Receipt number | R000024302 |
Scientific Title | Effects of host factors, virulent starins, and bacteriophage on therapies of Clostridium difficile infection including fecal microbiota transplantation |
Date of disclosure of the study information | 2016/02/22 |
Last modified on | 2016/02/26 18:37:23 |
Effects of host factors, virulent starins, and bacteriophage on therapies of Clostridium difficile infection including fecal microbiota transplantation
Host factors, virulent starins, and phage against Clostridium difficile infection therapy
Effects of host factors, virulent starins, and bacteriophage on therapies of Clostridium difficile infection including fecal microbiota transplantation
Host factors, virulent starins, and phage against Clostridium difficile infection therapy
Japan |
Clostridium difficile infection
Gastroenterology |
Others
YES
To determine the effects of host factors, Clostridium difficile strains(toxinA/B, binary toxin, PCR-ribotype), and bactriopahge on 3 groups such as vancomycin-sensitive, FMT-sensitive, and FMT-resistant groups
Safety,Efficacy
Exploratory
Pragmatic
Phase I
Pre-treatment differences of Clostridium difficile strains(toxinA/B, binary toxin, PCR-ribotype) among vancomycin-sensitive, FMT-sensitive, and FMT-resistant groups
1. Pre-treatment differences of host factors and phages among vancomycin-sensitive, FMT-sensitive, and FMT-resistant groups
2. Changes of Clostridium difficile strains(toxinA/B, binary toxin, PCR-ribotype) and phages 8 and 24 weeks after FMT
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Maneuver | Other |
fecal microbiota transplantation
0 | years-old | <= |
Not applicable |
Male and Female
Patients with symptomatic Clostridium difficile infection treated by vancomycin
1)Allergy to drugs used
2)Pregnant or probably pregnant women
3)Patients who are considered unsuitable by doctors
50
1st name | |
Middle name | |
Last name | Naoki Ohmiya |
Fujita Health University
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
Department of Gastroenterology
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
0562-93-9240
nohmiya@fujita-hu.ac.jp
Fujita Health University
Fujita Health University
Self funding
National Institute of Infectious Diseases, Kitasato University, Azabu University
NO
藤田保健衛生大学病院(愛知県)
2016 | Year | 02 | Month | 22 | Day |
Unpublished
Open public recruiting
2015 | Year | 10 | Month | 29 | Day |
2016 | Year | 02 | Month | 17 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2016 | Year | 02 | Month | 21 | Day |
2016 | Year | 02 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024302
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |