UMIN-CTR Clinical Trial

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