Clinical trial NCT02743234: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Official title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Difficile Infection
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of patients with clinical resolution 1 week after primary treatment
timeFrame: 1 week
measure: Number of patients with clinical resolution 8 weeks after primary treatment
timeFrame: 8 weeks
measure: Number of patients with clinical resolution 26 weeks after primary treatment
timeFrame: 26 weeks
measure: Number of patients with microbiological resolution week 1
timeFrame: 1 week
measure: Number of patients with microbiological resolution week 8
timeFrame: 8 weeks
measure: Number of patients with microbiological resolution week 26
timeFrame: 26 weeks
measure: Number of patients with global resolution (Clinical and microbiological resolution) week 1
timeFrame: 1 week
measure: Number of patients with global resolution (Clinical and microbiological resolution) week 26
timeFrame: 26 weeks
measure: Numerical change in quality of life (EQ5D-3L) week 8 and 26
timeFrame: 8 and 26 weeks
measure: Microbiota pattern changes 1, 8 and 26 weeks
timeFrame: 1, 8 and 26 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Associate professor
name: Jens F Dahlerup, MD DrMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammeken LH, Baunwall SMD, Dahlerup JF, Hvas CL, Ehlers LH. Health-related quality of life in patients with recurrent Clostridioides difficile infections. Therap Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.
citation: Hvas CL, Dahl Jorgensen SM, Jorgensen SP, Storgaard M, Lemming L, Hansen MM, Erikstrup C, Dahlerup JF. Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection. Gastroenterology. 2019 Apr;156(5):1324-1332.e3. doi: 10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2.