Biotherapy for MRSA Enterocolitis

Methicillin-Resistant Staphylococcus Aureus Clinical Trial

Official title:

Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02390622
• Other study ID #: MRSA-FMT
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2015
• Last updated: March 11, 2015
• Start date: July 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2015
• Source: Jinling Hospital, China
• Contact: Ning Li, MD
• Phone: 86-25-80863736
• Email: liningrigs[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1.infectious diarrhea caused by other pathogenic bacteria

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterocolitis
• Methicillin-Resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

Other:
• Fecal microbiota transplantation
bacteria liquid from 60g fecal was infusion via nasointestinal tube for three days

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Species diversity in fecal		one month after FMT	No