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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026874
Receipt No. 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 2019/04/08

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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
Email 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
Email dada@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

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
Email 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
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
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
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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