Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

NCT03712722 | Unknown

• 1 other identifier: 1-16-02-15-16
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Resolution of Clostridium difficile-Associated disease (CDAD)

  Number of patients with resolution of CDAD, , defined by the absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) or, in the case of abnormal stool frequency or consistency, a negative Clostridium difficile toxin test week 8

  8 weeks

Secondary Outcomes (2)

• Clinical effect week 8

  8 weeks

• Negative CD test week 8

  8 weeks

Study Arms (1)

rCDI

Adult patients with recurrect Clostridium difficile infection

Other: Faecal microbiota transplantation (FMT)

Interventions

Faecal microbiota transplantation (FMT) OTHER

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

rCDI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with recurrent Clostridium difficile infection

You may qualify if:

• age 18 or higher
• documented recurrence of Clostridium difficile

You may not qualify if:

• none

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Related Publications (4)

• 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.

  PMID: 40606527 DERIVED

• 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.

  PMID: 38871148 DERIVED

• 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.

  PMID: 37482926 DERIVED

• 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.

  PMID: 37062804 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples, plasma

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Christian L Hvas, MD PhD

CONTACT

+4528351839; christian.hvas@auh.rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD PhD

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)