UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020136
Receipt number R000023249
Scientific Title Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Date of disclosure of the study information 2015/12/10
Last modified on 2016/02/03 17:22:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.

Acronym

FMT for IBD and CDI

Scientific Title

Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.

Scientific Title:Acronym

FMT for IBD and CDI

Region

Japan


Condition

Condition

ulcerative colitis, Crohn's disease, and clostridium difficile infection.

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To determine the safety, usefulness, and compliance of FMT for ulcerative colitis, Crohn's disease, and clostridium difficile infection.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Adverse events of FMT, change of activity scores of patients with IBD and symptoms of patients with CDI by FMT

Key secondary outcomes

Change of gut microbiota by FMT


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

0 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)CDI
recurrent or refractory CDI by vancomycin
2)IBD
IBD not responded by conventional therapy including 5ASA, corticosteroid, and biologics

Key exclusion criteria

(1)Recipient
1)Allergy to drugs used in FMT
2)Pregnant or possible pregnant
3)Judged as unsuitable by researchers
(2)Donor
1)Malignancy, active or choronic infection
2)pregnant
3)3)Judged as unsuitable by researchers

Target sample size

23


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Ohmiya

Organization

Fujita Health University

Division name

Department of Gastroenterology

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho

TEL

0562-93-9240

Email

nohmiya@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Ohmiya

Organization

Fujita Health University

Division name

Department of Gastroenterology

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho

TEL

0562-93-9240

Homepage URL


Email

shokakan@fujita-hu.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Fujita Health University

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


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

藤田保健衛生大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 10 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


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

Open public recruiting

Date of protocol fixation

2015 Year 08 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 09 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

Prospective cohort study of patietns enrolled from Dec 9,2015 to Dec 31, 2022.Recipient's clinical symptoms, fecal microbiota, C.difficile toxins, ribotyping, blood analysis, endoscopic findings, enterocolonographic findigns, CT findings, depression score, BMI. Donor's fecal microbiota, CD toxins, ribotyping,blood analysis, endoscopic findings, enterocolonographic findigns, CT findings, depression score, BMI.


Management information

Registered date

2015 Year 12 Month 09 Day

Last modified on

2016 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name