UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012814 |
|---|---|
| Receipt number | R000014955 |
| Scientific Title | Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases |
| Date of disclosure of the study information | 2014/01/10 |
| Last modified on | 2019/07/17 23:46:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases
Acronym
Fecal microbiota transplantation in bowel diseases
Scientific Title
Safety and efficacy of fecal microbiota transplantation in intractable bowel diseases
Scientific Title:Acronym
Fecal microbiota transplantation in bowel diseases
Region
| Japan |
Condition
Condition
Ulcerative colitis, Intestinal Behcet, Clostridium difficile infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of fecal microbiota transplantation in intractable bowel disease patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Efficacy
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
Administration of feces obtained from healthy donors to patients.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Ulcerative colitis patients with moderate to severe activity despite treatment with corcicosteroids, anti-TNFa Ab, tacrolimus or immunomodulators.
2. Patients with intestinal Behcet's disease who have ulcers in the intestine despite treatment with corcicosteroids or anti-TNFa Ab.
3. Patients with C. difficile infection who have gastrointestinal symptoms despite administration of vancomycin or metronidazole.
4. Donors should be patient's spouse or first- or second-degree relatives.
Key exclusion criteria
1. Donors who show abnormal findings to the screening tests including blood and feces.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
1608582
Address
35 Shinano-machi, Shinjuku Tokyo
TEL
03-3353-1211
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Nanki |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
1608582
Address
35 Shinano-machi, Shinjuku Tokyo
TEL
03-3353-1211
Homepage URL
kosakun214@hotmail.com
Sponsor or person
Institute
Division of Gastroenterology and Hepatology,Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology,Department of Internal Medicine, Keio University School of Medicine
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
Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku, Tokyo
Tel
0333531211
kosakun214@hotmail.com
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
| 2014 | Year | 01 | 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
| 2013 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | 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
| 2014 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014955
