UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014955