UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030825