UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026874 |
|---|---|
| Receipt number | R000030825 |
| Scientific Title | Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2022/03/12 09:51:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis
Acronym
Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis
Scientific Title
Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis
Scientific Title:Acronym
Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis
Region
| Japan |
Condition
Condition
Clostridium difficile enteritis
Classification by specialty
| Medicine in general | Gastroenterology | Infectious disease |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and effectiveness of fecal microbiota transplantation as a treatment for intractable recurrent Clostridium difficile enteritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cure rate of Clostridium difficile enteritis within 6 months
Incidence of adverse events due to fecal microbiota transplantation (FMT)
Key secondary outcomes
Improvement of intestinal microflora before and after fecal microbiota transplantation therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Diluted faeces of relatives within the third parents are once administered into patien's colon using the lower gastrointestinal endoscope
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Clostridium difficile or Clostridium difficile antigen were detected from feces
2) Patients who did not cure Clostridium difficile enteritis with traditional antibiotic therapy or had a high probability of recurrence of Clostridium difficile enteritis
3) Age at the time of obtaining informed consent is greater than or equal to 20 years.
4) Patients who can eat foods orally.
5) Patients who write document consent by their own will after our explain.
Key exclusion criteria
1) Patients who have malignant tumors or serious systemic diseases (central nervous disease, psychiatric disorders) or poor general condition
2) Patients who already have gastrointestinal disease.(i.e. Crohn's disease, intestinal tuberculosis)
3) Patients who have swallowing disorder
4) Patients who have severe liver disease (AST or ALT >=100 IU/L)
5) Patients who have severe kidney disease (serum Cre >= 2.0 mg/dL)
6) Pregnant or lactating women
7) Patients who are judged by doctors as inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
5458585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
dada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
Homepage URL
dada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB center
Address
1-2-7 asahimachi abenoku osaka city
Tel
06-6645-3456
irb@med.osaka-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 05 | 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
4
Results
Four transplants were performed, and data collected.
After that, due to the COVID-19 epidemic, no more cases were enrolled and the study was terminated.
Results date posted
| 2022 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
None
Date of the first journal publication of results
Baseline Characteristics
None
Participant flow
None
Adverse events
None
Outcome measures
None
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030825
