Fecal Microbiota Transplantation by Colonoscopy for Recurrent C. Difficile Infection

NCT02148601 | Completed Phase 2

• 1 other identifier: A1192013
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

In the recent past, a deep change in the epidemiology of C. difficile infection has occurred, with a rise in its frequency, severity, and mortality. Both the refractoriness of the infection to standard therapy and its probability of recurrence have also increased, representing a main clinical issue. Fecal microbiota transplantation (FMT) refers to the introduction of a liquid filtrate of stools from a healthy donor into the gastrointestinal tract of a patient for the treatment of specific diseases. FMT has shown outstanding results in the treatment of recurrent C. difficile infection. It can be performed through various routes: nasogastric or nasojejunal tube, upper endoscopy, retention enema, colonoscopy. In a recent systematic review of studies using FMT for the treatment of recurrent C. difficile infection, Cammarota et al. observed that lower gastrointestinal route (colonoscopy, enema) led to the achievement of higher eradication rates than upper delivery (gastroscopy, naso-gastric or naso-jejunal tube) (81-86% vs 84-93%, respectively). In a randomized clinical trial, Van Nood et al. showed the efficacy of FMT by nasojejunal tube in recurrent C. difficile infection. Up to now, data on FMT by lower route come out only by case series and case reports. The investigators' aim is to compare the efficacy of colonoscopic FMT and standard antibiotic therapy for the treatment of C. difficile infection in a randomized clinical trial

Conditions

Clostridium Difficile

Keywords

Fecal microbiota transplantation; Recurrent Clostridium difficile infection; Colonoscopy; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Disappearance of clinical symptoms linked to C. difficile infection

  10 weeks

Secondary Outcomes (1)

• Negativization of C. difficile toxin in stools

  10 weeks

Study Arms (2)

Fecal Microbiota Transplantation

EXPERIMENTAL

Fecal microbiota transplantation from healthy donors will be infused by colonoscopy

Other: Fecal Microbiota Transplantation; Drug: Vancomycin (before randomization)

Standard Antibiotic Therapy

ACTIVE COMPARATOR

Standard antibiotic therapy according to European Guidelines (vancomycin and metronidazole) will be administered to the patients

Drug: Standard Antibiotic Therapy; Drug: Vancomycin (before randomization)

Interventions

Fecal Microbiota Transplantation OTHER

Fecal Microbiota Transplantation

Standard Antibiotic Therapy DRUG

Standard Antibiotic Therapy

Vancomycin (before randomization) DRUG

Vancomycin will be administered in all patients for 5 days before randomization. Then, patients will be randomized in FMT Group or Standard Antibiotic therapy Group. Patients in the FMT Group will stop vancomycin 24 hours before the fecal microbiota transplantation. Patients in the Standard Antibiotic Therapy Group will continue vancomycin.

Fecal Microbiota Transplantation; Standard Antibiotic Therapy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic recurrent C. difficile infection identified by positivity of C. difficile toxin in stools (ELISA)
• 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
• Main comorbidities
• Prior colectomy
• Negativity of C. difficile toxin in stools
• 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

Study Sites (1)

Catholic University of Sacred Heart - "A. Gemelli" University Hospital

Rome, 00168, Italy

Location

Related Publications (3)

• Cammarota G, Ianiro G, Bibbo S, Gasbarrini A. Gut microbiota modulation: probiotics, antibiotics or fecal microbiota transplantation? Intern Emerg Med. 2014 Jun;9(4):365-73. doi: 10.1007/s11739-014-1069-4. Epub 2014 Mar 25.

  PMID: 24664520 BACKGROUND

• Cammarota G, Ianiro G, Gasbarrini A, Masucci L, Sanguinetti M. Faecal transplantation for Clostridium difficile infection. Three cases treated in Italy. Dig Liver Dis. 2014 May;46(5):475. doi: 10.1016/j.dld.2013.12.011. Epub 2014 Jan 20. No abstract available.

  PMID: 24457126 BACKGROUND

• Cammarota G, Ianiro G, Gasbarrini A. Fecal microbiota transplantation for the treatment of Clostridium difficile infection: a systematic review. J Clin Gastroenterol. 2014 Sep;48(8):693-702. doi: 10.1097/MCG.0000000000000046.

  PMID: 24440934 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation; Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; 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: Prof. Giovanni Cammarota

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

IT (1)