UMIN-CTR Clinical Trial

Basic information
Public title	Infusion of Donor Feces for Recurrent Clostridium difficile Infection
Acronym	Donor Feces for Clostridium difficile Infection
Scientific Title	Infusion of Donor Feces for Recurrent Clostridium difficile Infection
Scientific Title:Acronym	Donor Feces for Clostridium difficile Infection
Region	Japan

Condition
Condition	Reccurent Clostridium difficile infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the infusion of feces from healthy donors is a safe and effective treatment for recurrent C. difficile infection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse rate of C. difficile infection within 10 weeks after donor fece infusion.
Key secondary outcomes	Disappearance of diarrhea. Negative C. difficile toxin. Change in enteric flora.

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	Infusion of feces from healthy donor.
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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Recurrent C. difficile infection even with enough treatment, i.e. vancomycin or metronidazole for more than 10 days.
Key exclusion criteria	1) Receiving other antibiotics for C. difficile infection. 2) Receiving prednisolone 1 mg/kg/day or more. 3) Treated in intensive care unit. 4) Receiving vasopressors. 5) Receiving immunosuppressants intravenously. 6) Receiving antibiotics for the purpose of digestive decontamination except for trimethoprim/sulfamethoxazole.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiji Kojima
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pediatrics
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL	+81-52-744-2294
Email	kojimas@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Nozomu Kawashima
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pediatrics
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL	+81-52-744-2294
Homepage URL
Email	kwnozomu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Department of Pediatrics
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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	No participants to the trial.
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	Terminated
Date of protocol fixation	2014 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date	2014 Year 01 Month 27 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 08 Month 13 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013431

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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