A Phase 2 interventional study of Single-infusion FMT and Vancomycin (before randomization) in Clostridium Difficile and Pseudomembranous Colitis, sponsored by Catholic University of the Sacred Heart. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.
Sponsored by Catholic University of the Sacred Heart · Phase 2, Interventional, and Treatment
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.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 29 interventional studies indexed under Enterocolitis, Pseudomembranous.
Browse Enterocolitis, Pseudomembranous studies →Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repeated fecal infusions by colonoscopy. Before FMT, vancomycin is administered in all patients for 3 days
Drug: Vancomycin (before randomization) · Biological: multiple-infusion FMT
Single fecal infusion by colonoscopy.Before FMT, vancomycin is administered in all patients for 3 days
Biological: Single-infusion FMT · Drug: Vancomycin (before randomization)
Patients will receive a single fecal infusion by colonoscopy
Vancomycin is administered in all patients for 3 days before randomization. Then vancomycin is stopped and patients are randomized to single-infusion FMT or multiple-infusion FMT.
Patients will receive multiple fecal infusions by colonoscopy
Cure of C. difficile infection
Disappearance of C. difficile-associated diarrhea
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Enterocolitis, Pseudomembranous →
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