Methicillin-Resistant Staphylococcus AureusNCT02390622
Biotherapy for MRSA Enterocolitis
A study testing Fecal microbiota transplantation in people with Methicillin-Resistant Staphylococcus Aureus, run by Jinling Hospital, China at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18-70 years old 2.patients diagnosed as MRSA enterocolitis
Who cannot join
- 1.infectious diarrhea caused by other pathogenic bacteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Ning Li, MD, +86-25-80863736, liningrigs@vip.sina.com
About this study
Official title: Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis
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.
Read the 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.
- Being tested
- Fecal microbiota transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
bacteria liquid from 60g fecal was infusion via nasointestinal tube for three days
| Study group | Role | What they receive |
|---|---|---|
| FMT treatment | Other | Treat the patients by fecal microbiota transplantation Receives: Other: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Species diversity in fecal
Measured: one month after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJul 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, weiyao, Jinling Hospital, China
- Investigators
- Ning Li, MD, Study director, Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University，
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390622
- Sponsor's protocol ID
- MRSA-FMT
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis
- ClinicalTrials.gov ID
- NCT02390622
- Acronym / sponsor ID
- MRSA-FMT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT treatment | Other | Other: Fecal microbiota transplantationTreat the patients by fecal microbiota transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18-70 years old 2.patients diagnosed as MRSA enterocolitis
Key exclusion criteria (1 listed)
- 1.infectious diarrhea caused by other pathogenic bacteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationbacteria liquid from 60g fecal was infusion via nasointestinal tube for three days | Other | FMT treatment |
Primary outcome
Species diversity in fecal
Time frame: one month after FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, MD study director
Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University，
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation in people with Methicillin-Resistant Staphylococcus Aureus, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, MD (86-25-80863736, liningrigs@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Species diversity in fecal (time frame: one month after FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.