None listed
Conditions
Brief summary
The emergence of bacteria or germs that have become resistant to most antibiotic treatments is an urgent public health problem. Often called “superbugs”, these germs have the ability to resist treatment with almost all antibiotics and can infect hospitalized as well as healthy people in the community. Superbugs transform previously easily treated minor infections into life-threatening conditions with very few treatment options. So far efforts to reduce superbug spread in our hospitals have failed to halt the global spread of these organisms. Nor are there new antibiotics in production to deal with this problem. New innovative approaches are needed to deal with this emerging threat. The faecal microbiota transplant, also called FMT, is a procedure where stool is collected from healthy donors and delivered to the gut of the recipient. This is done with the goal of the healthy bacteria from the donor replacing the harmful bacteria in the recipient. The FMT procedure is already proven safe and effective in treating patients with another type of bacterial gut infection called Clostridium difficile. FMT has also been shown in animal studies and human cases to eliminate gut carriage of certain superbugs called multi-resistant gram negative bacteria. The elimination of gut carriage would both prevent superbug infections developing in the individual and also prevent the spread of these organisms to other persons. In order to address this growing problem we have designed a study to test the effectiveness of FMT in people who have suffered from recurrent infections with a type of superbug. The goals of this study are to determine if FMT can result in clearance of superbug bacteria from the stool and to observe the effect of FMT on rates of recurrent infections in study participants. In collaboration with South Australian experts in this field the stool will be analysed to determine how FMT affects the range of germs in the gut and their ability to become resistant to antibiotics. If successful this study will represent a major scientific advance in our ability to prevent superbug infection and spread. It will open up new treatment possibilities for patients who suffer from superbug infections and benefit the community at large by giving us a new tool to stop the spread of superbugs to others.
Interventions
Participants in the intervention group will receive faecal microbiota transplantation (FMT) via enema from donor stool. Participants will receive enemas weekly for three weeks in total.
Faecal transplants will contain stool from healthy donors who are rigorously screened for infection or co-morbid conditions prior to donation. The stool donations are processed by the principal investigator who is a physician (FRACP) and clinical microbiologist (FRCPA). The stool is transferred to an anaerobic
Participants in the intervention group will receive faecal microbiota transplantation (FMT) via enema from donor stool. Participants will receive enemas weekly for three weeks in total. Faecal transplants will contain stool from healthy donors who are rigorously screened for infection or co-morbid conditions prior to donation. The stool donations are processed by the principal investigator who is a physician (FRACP) and clinical microbiologist (FRCPA). The stool is transferred to an anaerobic biosafety chamber within 2 hours of passage to preserve the microbes and blended with sterile normal saline and pharmaceutical grade glycerol within the chamber. The final composition of the faecal transplant contians 25% stool, 65% saline and 10% glycerol. Individual transplants are frozen at -80C . The transplants from a minimum of 3 to a maximum of 10 donors will subsequently be pooled prior to the transplants being administered so that every participant in the trial receives the same FMT. Each transplant consists of a 67mL enema. These will be administered by one of the study investigators all of whom are trained physicians. The procedure should take no more than 30 minutes.
Sponsors
The Queen Elizabeth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with refractory or recurrent infection–defined as at least 3 episodes of infection requiring at least 3 episodes of antibiotic therapy in preceding 24 months. 2. These infections were caused by a Gram negative bacterium which has acquired clinically important antibiotic resistance. This is defined as reported resistance to one or more of the following antibiotics: meropenem, ceftriaxone, cefepime, ceftazidime, cefalexin, amoxicillin-clavulanate, piperacillin-tazobactam, ciprofloxacin, gentamicin or trimethoprim.
Exclusion criteria
1. Active gastrointestinal infection Ie bacterial or viral infection causing symptoms of diarrhoea (colonisation with MRGNB is not considered to be an infection) 2. Pregnancy 3. Current use of antibiotics* 4. Cognitive impairment 5. Perianal inflammation 6. Life expectancy < 1 year 7. Neutropaenia <0.5 X109/L 8. Severe IgE mediated food allergy : urticaria or anaphylaxis 9. At risk of peritonitis: including patients with ascities or peritoneal dialysis *The use of trimethoprim-sulfamethoxazole is allowed when used for prophylaxis against Pneumocystis infection in immunosuppressed individuals.
Outcome results
None listed