UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary study for examining the safety and efficacy of fecal transplantation therapy in refractory intestinal diseases
Acronym	fecal transplantation therapy
Scientific Title	Preliminary study for examining the safety and efficacy of fecal transplantation therapy in refractory intestinal diseases
Scientific Title:Acronym	fecal transplantation therapy
Region	Japan

Condition
Condition	refractory intestinal diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	therapeutic effect of fecal transplantation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement of symptom
Key secondary outcomes	details of adverse events related to the therapy

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	Maneuver
Interventions/Control_1	fecal 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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	A. Patients with intestinal diseases which are refractory to medication. B. patient who had been scheduled lower gastrointestinal endoscopy examination
Key exclusion criteria	A. patient who does not agree to this study B. pregnancy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masanao Middle name Last name Nakamura
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	4558550
Address	65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-741-2111
Email	makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Masanao Middle name Last name Nakamura
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	4558550
Address	65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-741-2111
Homepage URL
Email	makamura@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya 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	Nagoya University ethic committee
Address	65, showa-ku, turumai-cho
Tel	052-741-2111
Email	ethic@med.nagoya-u.ac.jp

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	2017 Year 05 Month 31 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	2017 Year 11 Month 03 Day
Date of IRB
Anticipated trial start date	2017 Year 11 Month 03 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	2017 Year 03 Month 02 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030292