Skip to main content
OpenTrials
Completed

NCT Number: NCT02743234

Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin

Exclusion criteria

  • Pregnancy or breastfeeding
  • Does not speak or understand the Danish language
  • Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
  • fulminant colitis which contraindicates medical treatment
  • physician's evaluation that the patient cannot tolerate project inclusion

Treatment and study plan

Fecal microbiota transplantation

Other

FMT follows 4-10 days of vancomycin 125 mg x 4 daily

Fidaxomicin

Drug

Fidaxomicin 200 mg x 2 daily for 10 days

Vancomycin

Drug

Vancomycin 125 mg x 4 daily for 10 days

Primary outcomes

  1. Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment

    Time frame: 8 weeks

    Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment

Secondary outcomes

  1. Number of patients with clinical resolution 1 week after primary treatment

    Time frame: 1 week

    Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 1 week after finishing allocated treatment

  2. Number of patients with clinical resolution 8 weeks after primary treatment

    Time frame: 8 weeks

    Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy

  3. Number of patients with clinical resolution 26 weeks after primary treatment

    Time frame: 26 weeks

    Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy

  4. Number of patients with microbiological resolution week 1

    Time frame: 1 week

    Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy

  5. Number of patients with microbiological resolution week 8

    Time frame: 8 weeks

    Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy

  6. Number of patients with microbiological resolution week 26

    Time frame: 26 weeks

    Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy

  7. Number of patients with global resolution (Clinical and microbiological resolution) week 1

    Time frame: 1 week

    Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 1 week after finishing allocated treatment, without need for rescue FMT or colectomy

  8. Number of patients with global resolution (Clinical and microbiological resolution) week 26

    Time frame: 26 weeks

    Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy

  9. Numerical change in quality of life (EQ5D-3L) week 8 and 26

    Time frame: 8 and 26 weeks

    EQ5D-3L (www.euroqol.com) measures self-reported quality of life in 5 dimensions (each three levels), rendering score from 5 (lowest and best) to 15 (highest and worst) plus an overall reporting of general well being (0, lowest, worst to 100, highest, best). Scoring is obtained week 0,8,26 after randomization. Numerical changes are documented and compared using non-parametric statistics

  10. Microbiota pattern changes 1, 8 and 26 weeks

    Time frame: 1, 8 and 26 weeks

    Microbiota profiling, 16S rRNA, absence or presence of specific genera

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: FACIT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.