UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022400 |
|---|---|
| Receipt number | R000025792 |
| Scientific Title | Investigation of improvement for the clinical condition of digestive tract diseases by fecal microbiota transplantation |
| Date of disclosure of the study information | 2016/05/21 |
| Last modified on | 2017/11/20 16:27:28 |
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Basic information
Public title
Investigation of improvement for the clinical condition of digestive tract diseases by fecal microbiota transplantation
Acronym
Fecal microbiota transplantation for the patients with ulcerative colitis
Scientific Title
Investigation of improvement for the clinical condition of digestive tract diseases by fecal microbiota transplantation
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomoo Nakagawa |
Organization
Chiba University Hospital
Division name
Department of gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba city
TEL
043-222-7171
tom20852@hospital.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Nakagawa |
Organization
Chiba University Hospital
Division name
Department of gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba city
TEL
043-222-7171
Homepage URL
tom20852@hospital.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 29 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025792
