FMT for Moderate to Severe CDI: A Randomised Study With Concurrent Stool Microbiota Assessment

NCT02570477 | Unknown DMC

• 1 other identifier: FMT-CDI-RCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Clostridium difficile infection (CDI) is a leading cause of hospital-associated gastrointestinal illness, associated with significant morbidity and mortality and has a high burden on health-care system. The incidence of CDI has increased to epidemic proportion worldwide over the past decade. Community-acquired CDI, elderly and hospitalized patients receiving antibiotics are the main group at risk for developing CDI. Currently, the first-line treatment for C. difficile-associated diarrhea includes cessation of the antibiotic implicated in the development of CDI, treatment with metronidazole or vancomycin and recently Fidaxomicin which is yet to be available in Hong Kong. However, disease recurrence is an increasing problem and 20% to 60% of patients experience at least one recurrence within a few weeks of completion of antibiotic treatment. Moreover, an increasing number of patients who require life-saving emergency colectomy experience persistent CDI after surgery. Until recently, an effective treatment against recurrent CDI is not available. Generally, repeated and extended courses of vancomycin are prescribed. Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has attracted great interest in recent years and is now recommended as the most effective therapy for CDI not responding to standard therapies. Systematic reviews of prospective trials, case series and one randomized controlled trial have shown an overall cure rate of close to 100%. More than 50% of patients stated they would have FMT as their preferred first treatment option if CDI were to recur. This proposal aims to investigate the efficacy of FMT as first line therapy in patients with severe CDI and to assess changes in the fecal microbiota after FMT using pyrosequencing techniques.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Number of participants cured without relapse within 10 weeks after the initiation of therapy

  Relapse is defined as diarrhea with a positive stool test for C. difficile toxin. An adjudication committee members who are not aware of the study-group assignment will make final decision on which patients are considered cured.

  10 weeks

Secondary Outcomes (4)

• 30-day mortality rate

  30 days

• 30-day colectomy rates

  30 days

• Number of day of hospital stay

  up to 30 days

• Changes in the stool microbiota after FMT measured using pyrosequencing

  30 days

Study Arms (2)

Fecal Microbiota Transplantatio

ACTIVE COMPARATOR

Fecal Microbiota Transplantation of stool from healthy donor to recipient.

Procedure: Fecal Microbiota Transplantation

Standard Therapy

ACTIVE COMPARATOR

125mg Vancomycin four times per day

Drug: Vancomycin

Interventions

Fecal Microbiota Transplantation PROCEDURE

Healthy donor is screened and donates feces. It will then be diluted with sterile saline, blended and filtered. Supernatant will be infused to recipient.

Also known as: FMT infusion

Fecal Microbiota Transplantatio

Vancomycin DRUG

125mg Vancomycin four times per day

Standard Therapy

Eligibility Criteria

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

You may qualify if:

• C. difficile infection defined as diarrhea (≥3 soft, loose or watery stools per day for at least 2 consecutive days or ≥8 soft or loose stools in 48 hours) and a positive stool test for C. difficile toxin; and
• Age ≥ 18; and
• Written informed consent obtained

You may not qualify if:

• The presence of human immunodeficiency virus (HIV) infection with a CD4 count of less than 240
• Pregnancy
• GI Bleeding
• Acute coronary syndrome

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Zuo T, Wong SH, Lam K, Lui R, Cheung K, Tang W, Ching JYL, Chan PKS, Chan MCW, Wu JCY, Chan FKL, Yu J, Sung JJY, Ng SC. Bacteriophage transfer during faecal microbiota transplantation in Clostridium difficile infection is associated with treatment outcome. Gut. 2018 Apr;67(4):634-643. doi: 10.1136/gutjnl-2017-313952. Epub 2017 May 24.

  PMID: 28539351 DERIVED

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 Officials

• Siew Chien Ng

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)