Clostridium Difficile InfectionCEFTANCT03712722
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
An observational study of Clostridium Difficile Infection and Clostridioides Difficile Infection, run by University of Aarhus at 1 site in Denmark.
Trial summary
Faecal microbiota transplantation (FMT) is used for Clostridioides difficile infection (CDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clostridium Difficile Infection, Clostridioides Difficile Infection
- What is being tested?
- Faecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Clostridioides difficile infection
Who may be able to join
- age 18 or higher
- documented Clostridioides difficile infection
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Christian L Hvas, MD PhD, +45 28351839, christian.hvas@auh.rm.dk
About this study
Official title: Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study
Faecal microbiota transplantation (FMT) is used for Clostridioides difficile infection (CDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).
Read the detailed description
Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) and associated treating hospitals as an integrated part of the project.
- Being tested
- Faecal microbiota transplantation (FMT)
- Keywords
- fecal microbiota transplantation
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transplantation (FMT)Other
FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces
| Study group | Role | What they receive |
|---|---|---|
| C. difficile infection | Adult patients with recurrent, first, refractory or fulminant Clostridioides difficile infection Receives: Other: Faecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (2)
Clinical effect week 8
Number of patients with clinical effect, defined by absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower)
Measured: 8 weeks
Negative CD test week 8
Number of patients with negative Clostridium difficile toxin test week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Lodberg Hvas, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712722
- Sponsor's protocol ID
- 1-16-02-15-16
- Acronym
- CEFTA
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data access agreement may be made upon request; contact to PI
Publications
Olesen RH, Larsen EB, Rubak T, Baunwall SMD, Paaske SE, Gregersen M, Foss CH, Erikstrup C, Krogh CB, Ehlers LH, Hvas CL. Cost-Effectiveness of Hospital-at-Home and Fecal Microbiota Transplantation in Treating Older Patients With Clostridioides difficile. Clin Infect Dis. 2025 Sep 16;81(2):348-354. doi: 10.1093/cid/ciaf104.
PubMed 40243343Rubak T, Baunwall SMD, Gregersen M, Paaske SE, Asferg M, Barat I, Secher-Johnsen J, Riis MG, Rosenbaek JB, Hansen TK, Orum M, Steves CJ, Veilbaek H, Hvas CL, Damsgaard EMS. Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial. Lancet Healthy Longev. 2024 Dec;5(12):100648. doi: 10.1016/j.lanhl.2024.100648. Epub 2024 Oct 30.
PubMed 39488230Paaske 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.
PubMed 40606527Paaske SE, Baunwall SMD, Rubak T, Ragard N, Kelsen J, Hansen MM, Lodrup AB, Lyhne S, Glavind E, Fernis CMC, Hald S, Erikstrup LT, Vinter-Jensen L, Lal S, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Improving Clinical Outcomes of Encapsulated Faecal Microbiota Transplantation for Clostridioides difficile Infection Through Empirical Donor Selection and Optimised Dosing: A Quality Improvement Study. Aliment Pharmacol Ther. 2026 Jan;63(2):276-287. doi: 10.1111/apt.70395. Epub 2025 Oct 6.
PubMed 41047993Paaske 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.
PubMed 38871148Baunwall 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.
PubMed 37482926Baek 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.
PubMed 37062804
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03712722
- Acronym / sponsor ID
- CEFTA / 1-16-02-15-16
- Keywords
- fecal microbiota transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Faecal microbiota transplantation (FMT) is used for Clostridioides difficile infection (CDI) 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
Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) and associated treating hospitals as an integrated part of the project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C. difficile infection | – | Other: Faecal microbiota transplantation (FMT)Adult patients with recurrent, first, refractory or fulminant Clostridioides difficile infection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Clostridioides difficile infection
Key inclusion criteria (2 listed)
- age 18 or higher
- documented Clostridioides difficile infection
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal microbiota transplantation (FMT)FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces | Other | C. difficile infection |
Primary outcome
Resolution of Clostridium difficile-Associated disease (CDAD)
Time frame: 8 weeks
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
2 secondary outcomes
Clinical effect week 8
Time frame: 8 weeks
Negative CD test week 8
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 40243343Olesen RH, Larsen EB, Rubak T, Baunwall SMD, Paaske SE, Gregersen M, Foss CH, Erikstrup C, Krogh CB, Ehlers LH, Hvas CL. Cost-Effectiveness of Hospital-at-Home and Fecal Microbiota Transplantation in Treating Older Patients With Clostridioides difficile. Clin Infect Dis. 2025 Sep 16;81(2):348-354. doi: 10.1093/cid/ciaf104.
- Results publication: PubMed 39488230Rubak T, Baunwall SMD, Gregersen M, Paaske SE, Asferg M, Barat I, Secher-Johnsen J, Riis MG, Rosenbaek JB, Hansen TK, Orum M, Steves CJ, Veilbaek H, Hvas CL, Damsgaard EMS. Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial. Lancet Healthy Longev. 2024 Dec;5(12):100648. doi: 10.1016/j.lanhl.2024.100648. Epub 2024 Oct 30.
- Results publication: PubMed 40606527Paaske 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.
- Results publication: PubMed 41047993Paaske SE, Baunwall SMD, Rubak T, Ragard N, Kelsen J, Hansen MM, Lodrup AB, Lyhne S, Glavind E, Fernis CMC, Hald S, Erikstrup LT, Vinter-Jensen L, Lal S, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Improving Clinical Outcomes of Encapsulated Faecal Microbiota Transplantation for Clostridioides difficile Infection Through Empirical Donor Selection and Optimised Dosing: A Quality Improvement Study. Aliment Pharmacol Ther. 2026 Jan;63(2):276-287. doi: 10.1111/apt.70395. Epub 2025 Oct 6.
- Results publication: PubMed 38871148Paaske 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.
- Derived from this study: PubMed 37482926Baunwall 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.
- Derived from this study: PubMed 37062804Baek 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.
- Centre for faecal microbiota transplantation at Aarhus University Hospital (CEFTA)Link provided by the sponsor.
- European FMT NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: No. data access agreement may be made upon request; contact to PI
Related trials for Clostridium Difficile Infection
Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile
RecruitingPhase 2
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Clostridioides Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection and Clostridioides Difficile Infection, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian L Hvas, MD PhD (+4528351839, christian.hvas@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Clostridium difficile-Associated disease (CDAD) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712722, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.