UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042418 |
|---|---|
| Receipt number | R000048417 |
| Scientific Title | Fecal microbiota transplantation for recurrent Clostridioides difficile infection |
| Date of disclosure of the study information | 2020/11/11 |
| Last modified on | 2020/11/16 14:56:37 |
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Basic information
Public title
Fecal microbiota transplantation for recurrent Clostridioides difficile infection
Acronym
Fecal microbiota transplantation for recurrent Clostridioides difficile infection
Scientific Title
Fecal microbiota transplantation for recurrent Clostridioides difficile infection
Scientific Title:Acronym
Fecal microbiota transplantation for recurrent Clostridioides difficile infection
Region
| Japan |
Condition
Condition
Recurrent Clostridioides difficile infection
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effectiveness and safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate of single FMT to recurrent CDI
A response is a condition in which there is no recurrence. Recurrence is defined as diarrhea (at least three loose or watery stools per day for two or more consecutive days) and positivity in the CD toxin stool test or positivity for Clostridioides difficile in the stool culture and presence of pseudomembrane.
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
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
<Inclusion criteria for recipients> (1) Patients with recurrent CDI were enrolled. Recurrent CDI was defined as recurrence within 10 weeks after the end of treatment despite the antibiotic treatment of C. difficile with vancomycin. In case of vancomycin intolerance, metronidazole or fidaxomicin should be fully administered. (2) CDI is defined as diarrhea (at least three loose or watery stools per day for two or more consecutive days) and positivity in the CD toxin stool test or positivity for C. difficile in the stool culture and presence of pseudomembrane. (3) The other disease should be properly excluded. (4) At least 16 years old (5) A person who can obtain written consent of the research participation by free will. In the case of a juvenile patient, the consent of the representative in addition to the patient should be obtained. Basically, the representative is selected from parents. Grandparents and relatives who live together are considered to be able to represent the intentions and interests of the patients. <Inclusion criteria for donors> (1) Healthy person from 16 years old or older and 60 years old or younger. (2) A person who can provide feces on the day of FMT (3) A person who can refrain from taking the food at least 5 days before FMT, if the recipient has a food allergy. (4) Those judged to be eligible as a result of screening tests (5) Donors eligibility means that the screening tests does not meet the donor exclusion criteria (see below), infections except for cytomegalovirus and EB virus are denied, and the donor questionnaire shows No except for question #1 and #10. (6) Regarding cytomegalovirus and EB virus, if the recipient is uninfected and the donor is already infected, it is judged as ineligible. (7) A person who can obtain written consent of the research participation by free will.
Key exclusion criteria
(1) Those who cannot obtain appropriate donors
(2) Immunosuppressive drugs (anti-cancer drugs, high-dose steroids (15 mg/day or more), calcineurin inhibitors, mTOR inhibitors, anti-TNF-a antibody, biologics that cause lynmphopenia (rituximab, anti-human thymocyte rabbit immunoglobulin etc.)
(3) HIV virus infection
(4) Decompensated cirrhosis
(5) Pregnant women
(6) Antibiotics other than recurrent Clostridioides difficile infection
(7) Patients who cannot tolerate colonoscopy
(8)Lymphocyte count(<750/mm3)
(9)IgG(<500mg/dL)
(10) Otherwise, if the attending doctor deems inappropriate
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Andoh |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Clinical Nutrition
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2544
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Seta-Tsukinowa, Otsu
Tel
077-548-2544
sb@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051190048
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 11 | 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
0
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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048417
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
