Status:
COMPLETED
Fecal Microbiota Transplantation for CRE/VRE
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Antimicrobial Resistance
Colonization
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multidrug-resistant organisms (MDRO) present an increasingly serious public health threat to the global community.The prevalence of various MDRO, including carbapenem-resistant Enterobacteriaceae (CRE...
Eligibility Criteria
Inclusion
- For cases:
- Age ≥18 years old
- Two or more stool or rectal swab positive for CRE or VRE at least one week apart.
- \[CRE is defined as presence of any Enterobacteriaceae with resistance to any of the carbapenems. VRE is defined as presence of Enterococcus species resistant to vancomycin.\]
- Not receiving antimicrobial therapy for at least 48 hours prior to infusion of FMT
- For controls:
- Age ≥18 years old
- Two or more stool or rectal swab positive for CRE or VRE at least one week apart.
- Not receiving antimicrobial therapy for at least 48 hours prior to infusion of FMT
- Refuse to consent for FMT infusion but consent for other study procedures listed in the protocol.
Exclusion
- Active infection with CRE or VRE requiring antimicrobial therapy
- Pregnancy
- Active gastrointestinal tract infection or inflammatory disorders
- Recent intra-abdominal surgery
- Short gut syndrome
- Use of medications which alter gastrointestinal motility at the time of inclusion
- Post-allogeneic hematopoietic stem cell transplant patients with history of gastrointestinal tract graft versus host disease
- Presence of intra-abdominal device which would increase risk of peritonitis
- ANC \<500/mm3
- HIV infection with CD4 \<200 cells/mm3
- On chemotherapy
Key Trial Info
Start Date :
February 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03479710
Start Date
February 10 2018
End Date
July 31 2022
Last Update
August 9 2022
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong