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Biotherapy for MRSA Enterocolitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by weiyao, Jinling Hospital, China.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
weiyao, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT02390622
First received: March 11, 2015
Last updated: NA
Last verified: March 2015
History: No changes posted
  Purpose
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 Intervention
Methicillin-Resistant Staphylococcus Aureus
Other: Fecal microbiota transplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis

Resource links provided by NLM:


Further study details as provided by weiyao, Jinling Hospital, China:

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

Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

1.infectious diarrhea caused by other pathogenic bacteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02390622

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

Locations
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
Investigators
Study Director: Ning Li, MD Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University,
  More Information

Responsible Party: weiyao, Institute of General Surgery, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02390622     History of Changes
Other Study ID Numbers: MRSA-FMT
Study First Received: March 11, 2015
Last Updated: March 11, 2015

Additional relevant MeSH terms:
Enterocolitis
Staphylococcal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 25, 2017