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Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06001333
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborators:
Severance Hospital
National Institute of Health, Korea
Information provided by (Responsible Party):
Seung Soon Lee, Chuncheon Sacred Heart Hospital

Study Description
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Brief Summary:

The goal of this unblinded randomized controlled trial is to evaluate the efficacy and safety of fecal microbiota transplantation for the decolonization of carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE) or vancomycin-resistant Enterococci (VRE) in the intestinal tract. The study is planned to be conducted to test the superiority hypothesis that the decolonization success rate in the FMT group is higher compared to the non-FMT group. Outcome analysis will be conducted through intention-to-treat analysis, modified intention-to-treat analysis, and per-protocol analysis.

The main questions it aims to answer are:

  • primary endpoint: Rate of Decolonization of Multidrug-Resistant Organisms (CP-CRE or VRE) at 1 Month After Fecal Microbiota Transplantation (FMT).
  • secondary endpoint: Rates of Multidrug-Resistant Organism decolonization at 3 months, 6 months, and 1 year after FMT / Post-FMT Multidrug-Resistant Organism Recolonization Rate and Infection Rate.

Patients colonized with multidrug-resistant organisms in the gastrointestinal tract are divided into two groups through obtaining written consent from the patients and random allocation: the Fecal Microbiota Transplantation group (FMT group), which receives FMT, and the control group (non-FMT group), which is observed without FMT. The decolonization status of multidrug-resistant organisms will be monitored every 3-7 days after FMT until three consecutive negative results.


Condition or disease Intervention/treatment Phase
Carbapenem-Resistant Enterobacteriaceae Vancomycin (Glycopeptide) Resistant Enterococcus (VRE) Procedure: fecal microbiota transplantation Not Applicable

Detailed Description:

The study is planned to be conducted at Chuncheon Sacred Heart Hospital and Severance Hospital, using randomization with equal allocation to allocate patients into FMT (Fecal Microbiota Transplantation) and non-FMT groups. The study parameters are set with an alpha error of 0.05 and beta error of 0.2. Considering the findings from previous research, a delta value (effect size) was determined for sample size calculation. Based on this calculated sample size, for CP-CRE, 80 patients will be recruited in the FMT group compared to 68 patients in the non-FMT group. For VRE, 48 patients will be recruited in the FMT group compared to 44 patients in the non-FMT group.

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.

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 a 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 outcome and their mechanisms.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation for the Decolonization of Multidrug-Resistant Organisms in the Intestinal Tract: An Unblinded Randomized Controlled Trial
Actual Study Start Date : September 18, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: FMT group
fecal microbiota transplantation using frozen or capsulized stool
 Procedure: fecal microbiota transplantation
Fecal microbiota transplantation will be conducted on patients using donor stool (frozen or capsulized stool) from a stool bank.
No Intervention: non-FMT group
Simple observation without intervention


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Decolonization of Multidrug-Resistant Organisms at 1 Month After Fecal Microbiota Transplantation (FMT) [ Time Frame: at 1 Month After Fecal Microbiota Transplantation (FMT) ]
    The decolonization rate at 1 month after FMT refers to the proportion of achieving three consecutive negative results within 1 month after the FMT procedure.


Secondary Outcome Measures :
  1. rates of Multidrug-Resistant Organism decolonization at 3 months, 6 months, and 1 year after Fecal Microbiota Transplantation (FMT) [ Time Frame: at 3 months, 6 months, and 1 year after Fecal Microbiota Transplantation (FMT) ]
    The decolonization rate at 1 month, 3 months, and 1 year after FMT refers to the proportion of achieving three consecutive negative results within 3 months, 6 months, and 12 months after the FMT procedure.

  2. Post-FMT Multidrug-Resistant Organism Recolonization Rate and Infection Rate within 1 year after FMT [ Time Frame: within 12 months after FMT ]
    The rates of re-colonization of decolonized multidrug-resistant organisms (CP-CRE or VRE) and clinical infection rates of MDROs within 1 year after FMT procedure.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individuals aged 20 and older.
  2. Those with confirmed carbapenemase-producing Enterobacteriaceae (CPE) from a rectal swab culture within the past week (class A, B, or D CPE).
  3. Those with confirmed vancomycin-resistant Enterococci (E. fecalis or E. faecium) from a rectal swab culture within the past week.
  4. Individuals who have agreed to undergo Fecal Microbiota Transplantation (FMT) procedures and to provide pre- and post-procedure stool samples.
  5. Individuals who have discontinued antibiotics for a period of 3 to 7 days prior to FMT procedure.

Exclusion Criteria:

  1. Patients with ongoing or anticipated acute treatment, including antibiotic therapy.
  2. Individuals with severe immunodeficiency.
  3. Cases where there is a risk due to upper gastrointestinal endoscopy or colonoscopy.
  4. Pregnant individuals, those who could become pregnant, and breastfeeding women.
  5. Cases where participation in the study is determined by the researcher not to be beneficial.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001333


Contacts
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Contact: Seung Soon Lee, MD, PhD +82-10-3379-9347 hushh93@gmail.com
Contact: Jun Yong Choi, MD, PhD +82-10-4073-9253 seran@yuhs.ac

Locations
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Korea, Republic of
Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Gangwon-do, Korea, Republic of, 24253
Contact: Seung Soon Lee, MD, PhD    +82-10-3379-9347    hushh93@gmail.com   
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jun Yong Choi, MD, PhD    82-10-4073-9253    seran@yuhs.ac   
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Severance Hospital
National Institute of Health, Korea
Investigators
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Principal Investigator: Seung Soon Lee, MD, PhD Chuncheon Sacred Heart Hospital
More Information
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Responsible Party: Seung Soon Lee, Associate Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT06001333    
Other Study ID Numbers: 2023-06-007
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung Soon Lee, Chuncheon Sacred Heart Hospital:
Carbapenem-Resistant Enterobacteriaceae
Vancomycin-Resistant Enterococci
Fecal Microbiota Transplantation
Gastrointestinal Microbiome