UMIN-CTR Clinical Trial

Basic information
Public title	Fecal microbiota transplantation for refractory Clostridium difficile infection
Acronym	Fecal microbiota transplantation for refractory Clostridium difficile infection
Scientific Title	Fecal microbiota transplantation for refractory Clostridium difficile infection
Scientific Title:Acronym	Fecal microbiota transplantation for refractory Clostridium difficile infection
Region	Japan

Condition
Condition	Refractory Clostridium difficile infection
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to confirm the efficacy and safety of fecal microbiota transplantation for refractory Clostridium difficile infection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence rate of Clostridium difficile infection in 2 months after fecal microbiota transplantation
Key secondary outcomes

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	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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Refractory Clostridium difficile infection (2)Refractory to single antibiotic treatment (2)After screening tests, donor and recipient should be matched and meet criteria for fecal microbiota transplantation.
Key exclusion criteria	(1)Unable to find donors (2)Immunocompromised (3)Pregnancy (4)Under antibiotics threrapy for targeting other than refractory Clostridium difficile infection (5)Infant (6)Unable to undergo colonoscopy (7)Attending physician has determined unsuitabe
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Andoh
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Zip code	520-2192
Address	Seta-Tsukinowa, Otsu
TEL	077-548-2217
Email	hqgastro@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Shigeki Middle name Last name Bamba
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Zip code	520-2192
Address	Seta-Tsukinowa, Otsu
TEL	077-548-2217
Homepage URL
Email	sb@belle.shiga-med.ac.jp

Sponsor
Institute	Akira Andoh
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Seta-Tsukinowa, Otsu
Tel	0775482544
Email	sb@belle.shiga-med.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	2015 Year 09 Month 30 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	8
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	Completed
Date of protocol fixation	2015 Year 09 Month 21 Day
Date of IRB	2015 Year 09 Month 21 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2020 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022175