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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000042418
Receipt No. 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

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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
Email 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
Email sb@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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