UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of fecal microbiota transplantation in patients with inflammatory bowel disease
Title of the study (Brief title)	Efficacy of fecal microbiota transplantation in patients with inflammatory bowel disease
Region	Japan

Condition
Condition	inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of fecal microbiota transplantation in patients with inflammatory bowel disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the rate of remission induction of patients treated with fecal microbiota transplantation
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	15 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as mild - moderate inflammatory bowel disease (ulcerative colitis, crohn disease, bechet disease) at our hospital and refractory to standard treatments
Key exclusion criteria	Patients with severe inflammatory bowel disease, those who are considered inappropriate by physicians, or those who do not agree with entering the study.
Target sample size	10

Research contact person
Name of lead principal investigator	Toshiharu Sakurai
Organization	Kinki university
Division name	Gastroenterology
Address	377-2 Ohno-higashi Osaka-sayama
TEL	072-366-0221
Email	sakurai@med.kindai.ac.jp

Public contact
Name of contact person	Toshiharu Sakurai
Organization	Kinki university
Division name	Gastroenterology
Address	377-2 Ohno-higashi Osaka-sayama
TEL	072-366-0221
Homepage URL
Email	sakurai@med.kindai.ac.jp

Sponsor
Institute	Kinki university
Institute
Department

Funding Source
Organization	Kinki university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 04 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 08 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 08 Day
Last modified on	2016 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024681