UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014617 |
|---|---|
| Receipt number | R000017009 |
| Scientific Title | Safety and efficacy of fecal microbiota transplantation in functional gastrointestinal disorders |
| Date of disclosure of the study information | 2014/07/23 |
| Last modified on | 2024/07/30 12:17:42 |
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Basic information
Public title
Safety and efficacy of fecal microbiota transplantation in functional gastrointestinal disorders
Acronym
Fecal microbiota transplantation in functional gastrointestinal disorders
Scientific Title
Safety and efficacy of fecal microbiota transplantation in functional gastrointestinal disorders
Scientific Title:Acronym
Fecal microbiota transplantation in functional gastrointestinal disorders
Region
| Japan |
Condition
Condition
Irritable bowel syndrome, Functional constipation, Functional diarrhea
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of fecal microbiota transplantation in patients with intractable functional gastrointestinal disorders
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy of fecal microbiota transplantation in patients with intractable functional gastrointestinal disorders
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with irritable bowel syndrome, functional constipation, functional diarrhea which are refractory to medication for more than 1 year.
2. 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
20
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine, 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 | Tatsuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
1608582
Address
35 Shinano-machi, Shinjuku Tokyo
TEL
03-3353-1211
Homepage URL
masaoka@z6.keio.jp
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 Ethics Committee
Address
35 Shinano-machi, Shinjuku Tokyo
Tel
03-5363-3611
med-rinri-jimu@adst.keio.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
| 2014 | Year | 07 | Month | 23 | 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 | 03 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017009
