Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection

NCT03427229 | Completed Phase 2

• 1 other identifier: 1206132017
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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 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

Conditions

Clostridium Difficile; Pseudomembranous Colitis

Keywords

fecal microbiota transplantation; Clostridium difficile infection; pseudomembranous colitis

Outcome Measures

Primary Outcomes (1)

• Cure of C. difficile infection

  Disappearance of C. difficile-associated diarrhea

  8 weeks

Study Arms (2)

Multiple-infusion FMT

EXPERIMENTAL

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-infusion FMT

ACTIVE COMPARATOR

Single fecal infusion by colonoscopy.Before FMT, vancomycin is administered in all patients for 3 days

Biological: Single-infusion FMT; Drug: Vancomycin (before randomization)

Interventions

Single-infusion FMT BIOLOGICAL

Patients will receive a single fecal infusion by colonoscopy

Single-infusion FMT

Vancomycin (before randomization) DRUG

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.

Multiple-infusion FMT; Single-infusion FMT

multiple-infusion FMT BIOLOGICAL

Patients will receive multiple fecal infusions by colonoscopy

Multiple-infusion FMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Related Publications (1)

• Ianiro G, Masucci L, Quaranta G, Simonelli C, Lopetuso LR, Sanguinetti M, Gasbarrini A, Cammarota G. Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection-single versus multiple infusions. Aliment Pharmacol Ther. 2018 Jul;48(2):152-159. doi: 10.1111/apt.14816. Epub 2018 May 30.

  PMID: 29851107 DERIVED

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous; Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: February 9, 2018
• Study Start: March 1, 2016
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share