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Biotherapy for MRSA Enterocolitis

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ClinicalTrials.gov Identifier: NCT02390622
Recruitment Status : Unknown
Verified March 2015 by weiyao, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
weiyao, Jinling Hospital, China

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.

Condition or disease Intervention/treatment Phase
Methicillin-Resistant Staphylococcus Aureus Other: Fecal microbiota transplantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis
Study Start Date : July 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement MRSA

Arm Intervention/treatment
FMT treatment
Treat the patients by fecal microbiota transplantation
Other: Fecal microbiota transplantation
bacteria liquid from 60g fecal was infusion via nasointestinal tube for three days

Primary Outcome Measures :
  1. Species diversity in fecal [ Time Frame: one month after FMT ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

1.infectious diarrhea caused by other pathogenic bacteria

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): NCT02390622

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Contact: Ning Li, MD 86-25-80863736 liningrigs@vip.sina.com

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China, Jiangsu
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Ning Li, MD    +86-25-80863736    liningrigs@vip.sina.com   
Sponsors and Collaborators
Jinling Hospital, China
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Study Director: Ning Li, MD Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University,
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Responsible Party: weiyao, Institute of General Surgery, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02390622    
Other Study ID Numbers: MRSA-FMT
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases