Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
NCT ID: NCT02743234
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2016-04-30
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FMT
Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor
Fecal microbiota transplantation
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
Fidaxomicin
10 days fidaxomicin 200 mg x 2 daily
Fidaxomicin
Fidaxomicin 200 mg x 2 daily for 10 days
Vancomycin
10 days vancomycin 125 x 4 daily
Vancomycin
Vancomycin 125 mg x 4 daily for 10 days
Interventions
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Fecal microbiota transplantation
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
Fidaxomicin
Fidaxomicin 200 mg x 2 daily for 10 days
Vancomycin
Vancomycin 125 mg x 4 daily for 10 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
99 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Jens F Dahlerup, MD DrMSc
Role: PRINCIPAL_INVESTIGATOR
Associate professor
Locations
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Aarhus University Hospital
Aarhus C, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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FACIT
Identifier Type: -
Identifier Source: org_study_id
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