Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04583098 |
| Other study ID # |
2020-08-006 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 14, 2019 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Chuncheon Sacred Heart Hospital |
| Contact |
Seung Soon Lee, MD |
| Phone |
+82-33-240-5599 |
| Email |
hushh93[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to assess the effect of fecal microbiota transplantation for the
decolonization of carbapenem-resistant Enterobacteriaceae or vancomycin-resistant Enterococci
in the gut.
Description:
This study is a prospective observational cohort study exploring the decolonization effect of
Fecal Microbiota Transplantation (FMT) in patients colonized with Carbapenem-resistant
Enterobacteriaceae (CRE) and Vancomycin-resistant Enterococci (VRE).
Patients who have provided written consent for participation in the study will be required to
maintain fasting starting from the evening before the procedure, after discontinuing
broad-spectrum antibiotics for a minimum of 3-7 days. Subsequently, a bowel preparation will
be carried out twice - the evening before and the morning of the procedure. Once the bowel
preparation is complete, 1 hour before the procedure, patients will receive loperamide to
reduce bowel movements and then proceed to the endoscopy suite.
Fecal microbiota transplantation (FMT) will be carried out with the acquired frozen donor
stool, which will be thawed for 2 hours at room temperature following purchase and delivery
from a stool bank, under the consent and supervision of the patient or guardian. Frozen stool
from carefully screened donors who have passed the rigorous screening of both Stage 1
clinical assessment and Stage 2 laboratory tests (including evaluation for antibiotic
resistance organisms) will be supplied from a stool bank of Microbiotix inc. (Hyun Soo Seo,
et al. Ann Lab Med 2021;41:424-428).
The FMT procedure will be conducted in collaboration with the research team in the Division
of Gastroenterology. During the procedure, no tissue biopsy or excessive endoscope insertion
will be performed. The FMT involves the simple infusion of thawed donor stool into the
terminal ileum under colonoscopy, which takes approximately 5-10 minutes. The procedure
carries minimal risk of bleeding, perforation, or aspiration. In most cases, it will be
performed under sedation with colonoscopy. If smooth insertion of the colonoscope or proper
visualization of the colon is hindered, or if colonic preparation is not successful,
Esophagogastroduodenoscopy (EGD) will be performed with sedation, and thawed donor stool will
be infused into the third portion of the duodenum. This procedure also poses minimal risk of
regurgitation or aspiration due to its anatomical and physiological characteristics. After
the procedure, the lower extremities will be elevated by about 30 degrees to prevent the
transplanted stool from exiting. A one-day fasting period will be maintained after the
procedure to facilitate successful engraftment of the transplanted stool, followed by the
gradual resumption of a regular diet. Following FMT, repeated rectal swab cultures will be
conducted to confirm three consecutive negative results for CP-CRE or VRE at 3-7 day
intervals.
In cases where encapsulated fecal material is used for FMT, it will be ingested along with
high-acid cranberry or orange juice. The capsules are specially designed to dissolve in
low-acidic environments, allowing them to reach the terminal ileum for safe administration
without the need for bowel preparation. On the first day, 15 capsules will be consumed,
followed by another 15 capsules on the second day, for a total of 30 capsules. Subsequently,
repeated rectal swab tests will be conducted to confirm three consecutive negative results
for CP-CRE or VRE at 3-day intervals.
According to patient random allocation, fecal samples and clinical metadata will be
periodically collected (prior to FMT, 1 month, 3 months, 6 months, and 12 months after FMT)
from both recipients and donors. These collected samples will undergo full-length 16S rRNA
sequencing and shotgun metagenomic sequencing to comprehensively analyze the gut microbiome.
Through this analysis, the aim is to elucidate the intestinal microorganisms associated with
decolonization outcomes and mechanisms.
