UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of improvement for the clinical condition of digestive tract diseases by fecal microbiota transplantation
Title of the study (Brief title)	Fecal microbiota transplantation for the patients with ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative Colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To assess the safety and efficacy of microbiota (fecus) transplantation using colonoscopy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Alteration of Lichitiger Index at 8 weeks after 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 group
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	16 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The patient with mild or moderate UC. 2) Duration of UC is more than 3 years. 3) The UC patient has more than 2 donner candidates for microbiota
Key exclusion criteria	1) The patient in intensive care units 2) The patient requires high doses of corticosteroid (1 mg/kg of body weight per day) 3) The patient who is treated with vasopressor 4) The patient who is unsutable to this study by the judgement of the attending physician
Target sample size	20

Research contact person
Name of lead principal investigator	Tomoo Nakagawa
Organization	Chiba University Hospital
Division name	Department of gastroenterology
Address	1-8-1 Inohana, Chuo-Ku, Chiba city
TEL	043-222-7171
Email	tom20852@hospital.chiba-u.jp

Public contact
Name of contact person	Tomoo Nakagawa
Organization	Chiba University Hospital
Division name	Department of gastroenterology
Address	1-8-1 Inohana, Chuo-Ku, Chiba city
TEL	043-222-7171
Homepage URL
Email	tom20852@hospital.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
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 05 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 29 Day
Anticipated trial start date	2015 Year 03 Month 30 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 05 Month 21 Day
Last modified on	2017 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025792