Clostridium Difficile Clinical Trial
Official title:
Randomized Clinical Trial: Single Versus Multiple-infusion Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for
recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves
satisfactory cure rates of recurrent CDI). However, several retrospective studies show that
severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion
FMT, suggesting that multiple fecal infusions are required to cure this condition.
This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is
more effective than single-infusion FMT in curing severe CDI
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for
recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves
satisfactory cure rates of recurrent CDI). However, several retrospective studies show that
severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion
FMT, suggesting that multiple fecal infusions are required to cure this condition.
This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is
more effective than single-infusion FMT in curing severe CDI
The investigators' study is an open-label randomized controlled trial, enrolling patients
with recurrent and refractory C. difficile infection with a severe clinical picture of the
disease.
At enrollment, C. difficile infection is defined as diarrhoea (at least 3 loose or watery
stools per day for 2 or more consecutive days, or at least 8 loose stools in 48 hours) and
positivity in the C. difficile toxin stool test.
Recurrent C. difficile infection is meant as the reappearance of clinical symptoms and
positivity of C. difficile toxin test within 8 weeks after the end of the previous therapy.
Refractory CDI is defined as CDI unresponsive to the antimicrobial treatment, namely
persistence of diarrhoea with CD toxin positive or persistent diarrhoea with toxin negative
in the absence of other possible causes of diarrhoea (e.g. IBS, IBD, non-CDI
antibiotic-associated diarrhea) Severe CDI is defined, according to the latest ESCMID
guidelines, as: Episode of CDI with one or more specific clinical (fever, haemodynamic
instability, respiratory failure which needs mechanical ventilation, signs and symptoms of
peritonitis, signs and symptoms of colonic ileus), laboratory (marked leukocytosis, rise in
serum creatinine and lactate, marked decrease of serum albumin), radiological (colon
distension, colonic wall thickening) or endoscopic (pseudomembranous colitis), symptoms and
signs of severe colitis or complicated course of disease.
Patients' stool are screened for detection of parasites and enteric bacterial pathogens to
exclude other infective pathogens. Patients with former colectomy, inflammatory bowel
diseases (IBD), irritable bowel syndrome (IBS), viral hepatitis, AIDS or syphilis will be
excluded.
Patients are instructed and invited to signal recurrent symptoms and diarrhea after
treatment. Monthly clinical and lab checks are performed for a period of 2 months after the
treatment.
Treatment procedures:
All patients start therapy with vancomycin for 3 days before of stratification, with random
allocation (1 to 1, through statistical software) to one of the two treatment schemes: 1)
single-infusion FMT by colonoscopy, with the infusion in the cecum - through the biopsy
channel - of 60-120 gr (depending on production) of donated feces, obtained from the donor
within 6 hours from transplantation, and manually homogenized in 100/200 ml of physiological
solution; colonoscopy will be performed by an expert endoscopist; preparation for colonoscopy
(four liters of a solution with saline laxatives) will be provided 2) multiple-infusion FMT
(with the same protocol of the other arm, but with repeated fecal infusions).
All patient will be instructed on hygiene rules to be followed at the patient's domicile to
avoid re-infections at home. Stool donors will be selected following recommendations from the
European FMT Working Group Consensus Conference.
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