UMIN-CTR Clinical Trial

Basic information
Public title	Fecal microbiota transplantation for Clostridium difficile infection
Acronym	Fecal microbiota transplantation for Clostridium difficile infection
Scientific Title	Fecal microbiota transplantation for Clostridium difficile infection
Scientific Title:Acronym	Fecal microbiota transplantation for 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 purpose of this study is to provide a fecal microbiota transplantation (FMT) as a treatment option for refractory Clostridium difficile infection (CDI).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence rate of CDI at 2 months after FMT
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	120 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Refractory CDI (2) Refractory to at least single antibiotic treatment (3) Eligible as a result of screening tests
Key exclusion criteria	(1) Unable to find appropriate donor (2) Immunosuppressive state including chemotherapy, HIV infection and prednisolone administration (3) Pregnancy (4) Antibiotic treatment other than refractory Clostridium difficile infection (5) Age under 20 years old (6) Unable to undergo colonoscopy (7) The attending physician determines that the subject is unsuitable for this study
Target sample size	5

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	hqmed2@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	Shiga University of Medical Science
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, Shiga
Tel	077-548-2217
Email	sb@belle.shiga-md.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	2016 Year 01 Month 27 Day

Related information
URL releasing protocol	https://www.shiga-med.ac.jp/hospital/doc/department/department/digestive_int/index.html
Publication of results	Unpublished

Result
URL related to results and publications	https://www.shiga-med.ac.jp/hospital/doc/department/department/digestive_int/index.html
Number of participants that the trial has enrolled	8
Results	8 patients were successfully treated with FMT
Results date posted	2021 Year 01 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Recurrent CDI patients
Participant flow	After screening, FMT was performed
Adverse events	None
Outcome measures	Response rate
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	2016 Year 01 Month 27 Day
Anticipated trial start date	2016 Year 01 Month 27 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	2016 Year 01 Month 27 Day
Last modified on	2021 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023943