Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

University of Aarhus64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clostridium Difficile Infection

Interventions

Fecal microbiota transplantationOTHER

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

FidaxomicinDRUG

Fidaxomicin 200 mg x 2 daily for 10 days

VancomycinDRUG

Vancomycin 125 mg x 4 daily for 10 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin Exclusion Criteria: 1. Pregnancy or breastfeeding 2. Does not speak or understand the Danish language 3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin 4. fulminant colitis which contraindicates medical treatment 5. physician's evaluation that the patient cannot tolerate project inclusion

Locations (1)

Aarhus University Hospital

Aarhus C, Denmark

Outcomes

Primary Outcomes

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

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

Time frame: 8 weeks

Secondary Outcomes

Number of patients with clinical resolution 1 week after primary treatment

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

Time frame: 1 week

Number of patients with clinical resolution 8 weeks after primary treatment

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

Time frame: 8 weeks

Number of patients with clinical resolution 26 weeks after primary treatment

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

Time frame: 26 weeks

Number of patients with microbiological resolution week 1

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

Time frame: 1 week

Data from ClinicalTrials.gov

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