UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012814
Receipt number R000014955
Scientific Title Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases
Date of disclosure of the study information 2014/01/10
Last modified on 2019/07/17 23:46:31

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Basic information

Public title

Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases

Acronym

Fecal microbiota transplantation in bowel diseases

Scientific Title

Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases

Scientific Title:Acronym

Fecal microbiota transplantation in bowel diseases

Region

Japan


Condition

Condition

Ulcerative colitis, Intestinal Behcet, Clostridium difficile infection

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of fecal microbiota transplantation in intractable bowel disease patients

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety
Efficacy

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

Administration of feces obtained from healthy donors to patients.

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Ulcerative colitis patients with moderate to severe activity despite treatment with corcicosteroids, anti-TNFa Ab, tacrolimus or immunomodulators.
2. Patients with intestinal Behcet's disease who have ulcers in the intestine despite treatment with corcicosteroids or anti-TNFa Ab.
3. Patients with C. difficile infection who have gastrointestinal symptoms despite administration of vancomycin or metronidazole.
4. Donors should be patient's spouse or first- or second-degree relatives.

Key exclusion criteria

1. Donors who show abnormal findings to the screening tests including blood and feces.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Kanai

Organization

Department of Internal Medicine, Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology

Zip code

1608582

Address

35 Shinano-machi, Shinjuku Tokyo

TEL

03-3353-1211

Email

takagast@z2.keio.jp


Public contact

Name of contact person

1st name Kosaku
Middle name
Last name Nanki

Organization

Department of Internal Medicine, Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology

Zip code

1608582

Address

35 Shinano-machi, Shinjuku Tokyo

TEL

03-3353-1211

Homepage URL


Email

kosakun214@hotmail.com


Sponsor or person

Institute

Division of Gastroenterology and Hepatology,Department of Internal Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology and Hepatology,Department of Internal Medicine, Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35, Shinanomachi, Shinjuku, Tokyo

Tel

0333531211

Email

kosakun214@hotmail.com


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

2014 Year 01 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

2013 Year 12 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 10 Day

Last modified on

2019 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name