Biotherapy for MRSA Enterocolitis
Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis
1 other identifier
interventional
10
1 country
1
Brief Summary
Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial infection. Along with the widely application of antibiotics around perioperative period, MRSA infection is increasing by years.Fecal microbial transplantation (FMT),infusion of fecal preparation from a healthy donor into the GI tract of a patient is being proposed as a novel therapeutic approach to modulate diseases associated with pathological imbalances within the resident microbiota, termed dysbiosis.It has been used to treat intestinal disease such as inflammatory bowel diseases and Clostridium difficile infection, but no reports are available on its role in treating MRSA enteritis yet. vancomycin is the first choice to treat MRSA but can also lead to an increase in antibiotic resistant organisms such as vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus and transfer of antibiotic resistance genes among the microbial community. So FMT seems a more harmless and reasonable measure to treat similar diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 17, 2015
March 1, 2015
2.6 years
March 11, 2015
March 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Species diversity in fecal
one month after FMT
Study Arms (1)
FMT treatment
OTHERTreat the patients by fecal microbiota transplantation
Interventions
bacteria liquid from 60g fecal was infusion via nasointestinal tube for three days
Eligibility Criteria
You may qualify if:
- years old 2.patients diagnosed as MRSA enterocolitis
You may not qualify if:
- infectious diarrhea caused by other pathogenic bacteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ning Li, MD
Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University，
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of General Surgery
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 17, 2015
Study Start
July 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 17, 2015
Record last verified: 2015-03