Clinical trial NCT01958463: Transplantation of Fecal Microbiota for Clostridium Difficile Infection
Official title: Transplantation of Fecal Microbiota for Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Clostridium Difficile Infection
Keywords: Clostridium Difficile Infection
Fecal Microbiota Transplantation
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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 :

  1. 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 :
     * ≥ 3 diarrhea per day for at least two days in a row or ≥ 8 loose stools a day for 48 hours.
     * a positive stool test for Clostridium Difficile toxin, or PCR / antigen detection.
  2. 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).
  3. A first infection in a patient who is intolerant or allergic to Lonkomitzin and metronidazole.

Exclusion Criteria:

* Participation in another clinical study.
* Inability to provide informed consent.
* A pregnant woman or breastfeeding.
* Severe neutropenia - below 500 neutrophils (blood counts).
* A significant immunosuppression (SCID, CVID, GVHD, using different preparations Aimonosofrsibiim , including prolonged corticosteroid therapy at doses equivalent to ≥ 20 mg prednisone per day for more than 4 weeks).
* Status of SIRS or hemodynamic/respiratory instability.
* Toxic Megacolon, ischemic colitis, Fulminant colitis or a higher than usual risk of colon perforatin during colonoscopy.
* HBV infection or hepatitis C or HIV.
* The use of antibiotics for the treatment of another disease at the time of inclusion.
* A history of previous or current autoimmune disease, a progressive/an uncontrolled disease of the kidney/liver/hematological system/endocrine system/ heart/neurological system, or a metabolic disease.
* An addiction to alcohol or drugs.

Primary outcomes:
measure: Clinical remission
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: Negative lab test for Clostridium Difficile
timeFrame: 8 weeks after treatment
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Gastroenterology Institute
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Zmir Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References: