FMT for recurrent CDI

Phase 2

• Conditions: D004761; Pseudomembranous colitis, Clostridium difficile; Recurrent Clostridioides difficile infection

• Registration Number: JPRN-jRCTs051190048
• Lead Sponsor: Andoh Akira

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Inclusion criteria for recipients
(1) Patients with recurrent Clostridioides difficile infection were enrolled. Recurrent Clostridioides difficile infection was defined as recurrence within 10 weeks after the end of treatment despite the antibiotic treatment of Clostridioides difficile with vancomycin (oral administration of vancomycin 500 mg/day or more for at least 10 days). In case of vancomycin intolerance, metronidazole (metronidazole at a dose of 750 mg/day or more for at least 10 days) or fidaxomicin (oral administration of fidaxomicin 400 mg/day or more for at least 10 days) should be administered.
(2) Clostridioides difficile infection 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.
(3) The following disease should be excluded; ulcerative colitis, Crohn's disease, radiation colitis, drug-induced colitis, follicular hyperplasia, ischemic colitis, intestinal Behcet's disease, irritable bowel syndrome, infectious enteritis such as bacterial dysentery, amebic colitis, Salmonella enteritis, Campylobacter enteritis, colonic tuberculosis, Chlamydia enteritis.
(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) Donor's 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. 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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate of single FMT to recurrent CDI<br>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.

Secondary Outcome Measures

Name	Time	Method
(1) Response rate after the first and second FMT for recurrent CDI<br>(2) Characteristics and rate of requiring second FMT <br>(3) Fecal microbiota analysis of recipients and donors<br>(4) Strain analysis of Clostridioides difficile isolated from recipients.