UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018642 |
|---|---|
| Receipt number | R000021579 |
| Scientific Title | A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis |
| Date of disclosure of the study information | 2015/08/11 |
| Last modified on | 2022/01/13 11:47:31 |
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Basic information
Public title
A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis
Acronym
A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis
Scientific Title
A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis
Scientific Title:Acronym
A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an efficacy of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of this treatment is evaluted by microbiota analysis, endoscopic score and bllod test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Antibiotics therapy:Taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks.
Interventions/Control_2
FMT:Administration of the fecal material from healthy donors to patients.
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Ulcerative colitis patients
2. Donors should be more than 20 years old.
Key exclusion criteria
1. Patients who have severe drug allergy are excluded.
2. Donors who show abnormal findings to the screening tests including blood and feces.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dai Ishikawa |
Organization
Juntendo university school of medicine
Division name
Department of gastroenterology
Zip code
Address
2-1-1Hongo, Bunkyoku Tokyo
TEL
03-3813-3111
dai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Ishikawa |
Organization
Juntendo university school of medicine
Division name
Department of gastroenterology
Zip code
Address
2-1-1Hongo, Bunkyoku Tokyo
TEL
03-3813-3111
Homepage URL
dai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university school of medicine Department of gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Juntendo university school of medicine Department of gastroenterology
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
| 2015 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 11 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021579
