UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020766
Receipt number R000023943
Scientific Title Fecal microbiota transplantation for Clostridium difficile infection
Date of disclosure of the study information 2016/01/27
Last modified on 2021/01/30 09:55:14

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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 or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023943


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name