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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020136
Receipt No. R000023249
Scientific Title Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Date of disclosure of the study information 2015/12/10
Last modified on 2016/02/03

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Basic information
Public title Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Acronym FMT for IBD and CDI
Scientific Title Safety and effectiveness of fecal microbiota transplantation for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Scientific Title:Acronym FMT for IBD and CDI
Region
Japan

Condition
Condition ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the safety, usefulness, and compliance of FMT for ulcerative colitis, Crohn's disease, and clostridium difficile infection.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Adverse events of FMT, change of activity scores of patients with IBD and symptoms of patients with CDI by FMT
Key secondary outcomes Change of gut microbiota by FMT

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)CDI
recurrent or refractory CDI by vancomycin
2)IBD
IBD not responded by conventional therapy including 5ASA, corticosteroid, and biologics
Key exclusion criteria (1)Recipient
1)Allergy to drugs used in FMT
2)Pregnant or possible pregnant
3)Judged as unsuitable by researchers
(2)Donor
1)Malignancy, active or choronic infection
2)pregnant
3)3)Judged as unsuitable by researchers
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho
TEL 0562-93-9240
Email nohmiya@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho
TEL 0562-93-9240
Homepage URL
Email shokakan@fujita-hu.ac.jp

Sponsor
Institute Department of Gastroenterology, Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health 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
Address
Tel
Email

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 藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 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
2015 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 09 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information Prospective cohort study of patietns enrolled from Dec 9,2015 to Dec 31, 2022.Recipient's clinical symptoms, fecal microbiota, C.difficile toxins, ribotyping, blood analysis, endoscopic findings, enterocolonographic findigns, CT findings, depression score, BMI. Donor's fecal microbiota, CD toxins, ribotyping,blood analysis, endoscopic findings, enterocolonographic findigns, CT findings, depression score, BMI.

Management information
Registered date
2015 Year 12 Month 09 Day
Last modified on
2016 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023249

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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