UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Effects of host factors, virulent starins, and bacteriophage on therapies of Clostridium difficile infection including fecal microbiota transplantation
Acronym
Host factors, virulent starins, and phage against Clostridium difficile infection therapy
Scientific Title
Effects of host factors, virulent starins, and bacteriophage on therapies of Clostridium difficile infection including fecal microbiota transplantation
Scientific Title:Acronym
Host factors, virulent starins, and phage against Clostridium difficile infection therapy
Region
| Japan |
Condition
Condition
Clostridium difficile infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Pre-treatment differences of Clostridium difficile strains(toxinA/B, binary toxin, PCR-ribotype) among vancomycin-sensitive, FMT-sensitive, and FMT-resistant groups
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | 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
| 0 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with symptomatic Clostridium difficile infection treated by vancomycin
Key exclusion criteria
1)Allergy to drugs used
2)Pregnant or probably pregnant women
3)Patients who are considered unsuitable by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Infectious Diseases, Kitasato University, Azabu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | 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
| 2015 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 21 | Day |
Last modified on
| 2016 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024302
