Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

NCT ID: NCT03712722

Last Updated: 2021-05-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2024-12-31

Brief Summary

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Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

Detailed Description

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Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.

Conditions

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Clostridium Difficile Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rCDI

Adult patients with recurrect Clostridium difficile infection

Faecal microbiota transplantation (FMT)

Intervention Type OTHER

FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces

Interventions

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Faecal microbiota transplantation (FMT)

FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 18 or higher
* documented recurrence of Clostridium difficile

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Christian Hvas

Associate professor, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Christian L Hvas, MD PhD

Role: CONTACT

+4528351839

Facility Contacts

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Christian L Hvas, MD PhD

Role: primary

+45 28351839

References

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Paaske SE, Baunwall SMD, Rubak T, Ragard N, Kelsen J, Hansen MM, Lodrup AB, Erikstrup LT, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Clinical management of Clostridioides difficile infection with faecal microbiota transplantation: a real-world cohort study. EClinicalMedicine. 2025 Jun 19;85:103302. doi: 10.1016/j.eclinm.2025.103302. eCollection 2025 Jul.

Reference Type DERIVED
PMID: 40606527 (View on PubMed)

Paaske SE, Baumwall SMD, Rubak T, Birn FH, Ragard N, Kelsen J, Hansen MM, Svenningsen L, Krarup AL, Fernis CMC, Neumann A, Lodrup AB, Glerup H, Vinter-Jensen L, Helms M, Erikstrup LT, Grosen AK, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection. Clin Gastroenterol Hepatol. 2025 Mar;23(4):602-611.e8. doi: 10.1016/j.cgh.2024.05.038. Epub 2024 Jun 11.

Reference Type DERIVED
PMID: 38871148 (View on PubMed)

Baunwall SMD, Hansen MM, Andreasen SE, Eriksen MK, Ragard N, Kelsen J, Grosen AK, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Donor, patient age and exposure to antibiotics are associated with the outcome of faecal microbiota transplantation for recurrent Clostridioides difficile infection: A prospective cohort study. Aliment Pharmacol Ther. 2023 Sep;58(5):503-515. doi: 10.1111/apt.17642. Epub 2023 Jul 22.

Reference Type DERIVED
PMID: 37482926 (View on PubMed)

Baek OD, Hjermitslev CK, Dyreborg L, Baunwall SMD, Hoyer KL, Ragard N, Hammeken LH, Povlsen JV, Ehlers LH, Hvas CL. Early Economic Assessment of Faecal Microbiota Transplantation for Patients with Urinary Tract Infections Caused by Multidrug-Resistant Organisms. Infect Dis Ther. 2023 May;12(5):1429-1436. doi: 10.1007/s40121-023-00797-y. Epub 2023 Apr 16.

Reference Type DERIVED
PMID: 37062804 (View on PubMed)

Other Identifiers

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1-16-02-15-16

Identifier Type: -

Identifier Source: org_study_id

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