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Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection.
The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.
Full description
Infections by Clostridium Difficile are common both in the community and among hospitalized patients. It is mostly prevalent following an antibiotic treatment. In recent years the investigators are witnessing an increase in severity, incidence and treatment-resistant cases.
Treatment-resistant infection or recurrent infection put the patient at risk for severe complications, such as perforation, septic shock, megacolon and even death.
New antibiotic treatments such as Rifaximin and Fidaxomicin are not yet available for routine use in Israel.
It is known that normal intestinal microbiota protect against Clostridium Difficile infections, and as early as 1958, researchers have demonstrated that a transplantation of fecal microbiota had a beneficial effect on Clostridium Difficile Infection.
In fact, previous data show that microbiota transplantation during colonoscopy, in patients with treatment-resistant infection or recurrent infections, is an effective method with a 90% success rate in a single treatment.
The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile infection.
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Inclusion criteria
age>18 years.
A negative pregnancy test at inclusion, and a commitment to use contraception for a period of six months from the date of transplant.
At least one of the following conditions :
An evidence of Clostridium infection recurrence within 6 months after completion of antibiotic course acceptable, which will include at least 10 days of treatment Bmtronidzol a total dose of 500 mg x3 per day and / or Bonkomitzin dose of at least 125 mg 4x a day .
Recurrence of infection is defined clinical and laboratory :
First infection not responding to antibiotics (at least 10 days Metronidazole dosage of 1500 mg per day , or Bonkomitzin total dose of at least 500 mg per day).
A first infection in a patient who is intolerant or allergic to Lonkomitzin and metronidazole.
Exclusion criteria
Primary purpose
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10 participants in 1 patient group
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Central trial contact
Zamir Halpern, MD
Data sourced from clinicaltrials.gov
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