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Biotherapy for MRSA Enterocolitis

Primary Purpose

Methicillin-Resistant Staphylococcus Aureus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methicillin-Resistant Staphylococcus Aureus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.18-70 years old 2.patients diagnosed as MRSA enterocolitis

Exclusion Criteria:

1.infectious diarrhea caused by other pathogenic bacteria

Sites / Locations

  • Department of General Surgery, Jinling hosptal,Medical School of Nanjing UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FMT treatment

Arm Description

Treat the patients by fecal microbiota transplantation

Outcomes

Primary Outcome Measures

Species diversity in fecal

Secondary Outcome Measures

Full Information

First Posted
March 11, 2015
Last Updated
March 11, 2015
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02390622
Brief Title
Biotherapy for MRSA Enterocolitis
Official Title
Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Five cases from July, 2013 to February, 2014 were collected in Jinling hospital.They developed unexplained high fever, bloating, nausea, vomit, a high stoma output or diarrhea in the color of yellow-green with copious amounts of mucus leading to dehydration and tachycardia after short time of operation (2-4d).We got the etiology diagnosis from all the patients' gastric juice cultures which revealed MRSA.Vancocin cp had a dissatisfied effect,so FMT was supplied for treating MRSA.All the patients had a decreased intestinal flora species before FMT and the content of staphylococcus aureus almost reached half of total intestinal flora . Patients' gut bacteria after FMT gradually agree with the donors' reflected the alleviative symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-Resistant Staphylococcus Aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT treatment
Arm Type
Other
Arm Description
Treat the patients by fecal microbiota transplantation
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
bacteria liquid from 60g fecal was infusion via nasointestinal tube for three days
Primary Outcome Measure Information:
Title
Species diversity in fecal
Time Frame
one month after FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.18-70 years old 2.patients diagnosed as MRSA enterocolitis Exclusion Criteria: 1.infectious diarrhea caused by other pathogenic bacteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, MD
Phone
86-25-80863736
Email
liningrigs@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Organizational Affiliation
Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University,
Official's Role
Study Director
Facility Information:
Facility Name
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
+86-25-80863736
Email
liningrigs@vip.sina.com

12. IPD Sharing Statement

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Biotherapy for MRSA Enterocolitis

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