Status:
COMPLETED
Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Clostridium Difficile
Pseudomembranous Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rat...
Detailed Description
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rat...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Recurrent C. difficile infection (identified by positivity of C. difficile toxin in stools) with severe clinical picture (defined by the ESCMID Guidelines published in 2014 - Debast et al, Clin Microbiol Infect 2014)
- Possibility to undergo standard antimicrobial therapy for recurrent C. difficile infection Approval of informed consent
- Possibility to undergo protocol diagnostic and therapeutic procedures
- Stool negativity for parasites
- Stool negativity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile
- Blood negativity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL).
- Exclusion Criteria:
- Subjects \<18 years old
- Prior colectomy
- Negativity of C. difficile toxin in stools
- Mild clinical picture of C. difficile infection
- High risk of post-colonoscopy complications
- Other main gastrointestinal diseases (es. Crohn's disease or ulcerative colitis)
- Stool positivity for parasites
- Stool positivity for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for C. difficile
- Blood positivity for: Hepatitis A virus-Immunoglobulin M, HBsAg, Anti-Hepatitis C Virus, Anti-Human Immunodeficiency Virus1-2, venereal disease reaction level (VDRL).
- Pregnancy or breastfeeding.
- Inability to follow protocol procedures
Exclusion
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03427229
Start Date
March 1 2016
End Date
October 30 2017
Last Update
February 9 2018
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