Clostridium Difficile InfectionEarlyFMTNCT04885946
Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
A study testing Fecal microbiota transplantion (FMT) in people with Clostridium Difficile Infection and Clostridioides Difficile Infection, run by Christian Lodberg Hvas at 1 site in Denmark.
Trial summary
Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Clostridium Difficile Infection, Clostridioides Difficile Infection
- What is being tested?
- Fecal microbiota transplantion (FMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jun 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. or 2. CDI (within a year) defined as: > 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
- Age 18 years or higher.
Who cannot join
- Pregnancy
- Does not speak or understand the Danish language
- Current antibiotic treatment other than vancomycin
- Current treatment with potential interations with vancomycin
- Allergy to vancomycin
- Previous anaphylactic reactions due to food allergies
Show all 9Show fewer
- Continuous need for proton pump inhibitor
- Documented gastroparesis
- Fulminant CDI
Trial locations and contacts
1 site in 1 country.
About this study
Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined.
In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.
Read the detailed description
This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.
- Being tested
- Fecal microbiota transplantion (FMT), Placebo
- Keywords
- Fecal microbiota tranplantation, FMT, CDI
- Medical subject headings
- Clostridium Infections, Diabetes Insipidus, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantion (FMT)Other
Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
PlaceboOther
Food coloring, water, glycerol
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation | Experimental | Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT. Receives: Other: Fecal microbiota transplantion (FMT) |
| Vancomycin 125 x 4 for 10 days + 2 Placebo | Placebo comparator | Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo. Receives: Other: Placebo |
| Open-label for screened, but not randomized patients with fulminant CDI | Other | This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical. Receives: Other: Fecal microbiota transplantion (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of CD-associated diarrhea (CDAD) week 8
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Measured: 8 weeks following treatment
Mortality week 8
In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.
Measured: 8 weeks following treatment
Secondary outcomes (6)
Resolution of CD-associated diarrhea (CDAD) week 1
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Measured: 1 week following treatment
Negative CD toxin-test week 1
Faecal C difficile PCR test
Measured: 1 week following treatment
Negative CD toxin-test week 8
Faecal C difficile PCR test
Measured: 8 weeks following treatment
Mortality week 8
Date of death
Measured: 8 weeks
Colectomy rate week 8
Date of colectomy
Measured: 8 weeks
Health-related quality of life
EDQ5D-5L
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 posted13 May 2021
- Study start2 Jun 2021
- Primary completion31 Mar 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Lodberg Hvas
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Sponsor-investigator, Christian Lodberg Hvas, University of Aarhus
- Investigators
- Christian L Hvas, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885946
- Sponsor's protocol ID
- 1-10-72-254-20
- Acronym
- EarlyFMT
- Status last verified
- Oct 2026
- First submitted
- 10 May 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be obtained in a anonymous form compliant with the General Data Protection Regulation (GDPR)
Publications
Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first and second episodes of Clostridioides difficile infection - Authors' reply. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):112-113. doi: 10.1016/S2468-1253(22)00424-1. No abstract available.
PubMed 36620981Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1083-1091. doi: 10.1016/S2468-1253(22)00276-X. Epub 2022 Sep 22.
PubMed 36152636Birch CR, Paaske SE, Jensen MB, Baunwall SMD, Ehlers LH, Hvas CL. Cost-effectiveness of faecal microbiota transplantation compared with vancomycin monotherapy for early Clostridioides difficile infection: economic evaluation alongside a randomized controlled trial. J Hosp Infect. 2025 Jan;155:145-149. doi: 10.1016/j.jhin.2024.11.003. Epub 2024 Nov 14.
PubMed 39547534
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 for Early Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT04885946
- Acronym / sponsor ID
- EarlyFMT / 1-10-72-254-20
- Keywords
- Fecal microbiota tranplantation, FMT, CDI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Christian Lodberg HvasUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 May 2021 (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.
Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined.
In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.
Detailed description
This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.
| Arm | Type | Receives |
|---|---|---|
| Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation | Experimental | Other: Fecal microbiota transplantion (FMT)Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT. |
| Vancomycin 125 x 4 for 10 days + 2 Placebo | Placebo comparator | Other: PlaceboPatients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo. |
| Open-label for screened, but not randomized patients with fulminant CDI | Other | Other: Fecal microbiota transplantion (FMT)This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. or 2. CDI (within a year) defined as: > 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
- Age 18 years or higher.
Key exclusion criteria (9 listed)
- Pregnancy
- Does not speak or understand the Danish language
- Current antibiotic treatment other than vancomycin
- Current treatment with potential interations with vancomycin
- Allergy to vancomycin
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 |
|---|---|---|
| Fecal microbiota transplantion (FMT)Single donor, fecal microbiota transplantion (FMT) from healthy human donors. | Other | Open-label for screened, but not randomized patients with fulminant CDI, Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation |
| PlaceboFood coloring, water, glycerol | Other | Vancomycin 125 x 4 for 10 days + 2 Placebo |
Primary outcome
Resolution of CD-associated diarrhea (CDAD) week 8
Time frame: 8 weeks following treatment
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Mortality week 8
Time frame: 8 weeks following treatment
In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.
6 secondary outcomes
Resolution of CD-associated diarrhea (CDAD) week 1
Time frame: 1 week following treatment
Negative CD toxin-test week 1
Time frame: 1 week following treatment
Negative CD toxin-test week 8
Time frame: 8 weeks following treatment
Mortality week 8
Time frame: 8 weeks
Colectomy rate week 8
Time frame: 8 weeks
Health-related quality of life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 36620981Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first and second episodes of Clostridioides difficile infection - Authors' reply. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):112-113. doi: 10.1016/S2468-1253(22)00424-1. No abstract available.
- Results publication: PubMed 36152636Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1083-1091. doi: 10.1016/S2468-1253(22)00276-X. Epub 2022 Sep 22.
- Results publication: PubMed 39547534Birch CR, Paaske SE, Jensen MB, Baunwall SMD, Ehlers LH, Hvas CL. Cost-effectiveness of faecal microbiota transplantation compared with vancomycin monotherapy for early Clostridioides difficile infection: economic evaluation alongside a randomized controlled trial. J Hosp Infect. 2025 Jan;155:145-149. doi: 10.1016/j.jhin.2024.11.003. Epub 2024 Nov 14.
- Centre for faecal microbiota transplantationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data may be obtained in a anonymous form compliant with the General Data Protection Regulation (GDPR)
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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. This study is not recruiting at the moment.
Christian L Hvas, PhD study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantion (FMT) in people with Clostridium Difficile Infection and Clostridioides Difficile Infection, run by Christian Lodberg Hvas 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 9 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: finished, 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of CD-associated diarrhea (CDAD) week 8 (time frame: 8 weeks following treatment). The study lists 2 primary outcomes in all. 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 NCT04885946, which also lists 3 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.