Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection

• Status: Completed
• Trial end date: 2017-10-30
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Vancomycin

Criteria

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