Clostridium Difficile InfectionPhase 3FACITNCT02743234
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
A Phase 3 study testing Fecal microbiota transplantation, Fidaxomicin and Vancomycin in people with Clostridium Difficile Infection, run by University of Aarhus at 1 site in Denmark.
Trial summary
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal microbiota transplantation, Fidaxomicin and Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to 31 Aug 2019
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin
Who cannot join
- Pregnancy or breastfeeding
- Does not speak or understand the Danish language
- Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
- fulminant colitis which contraindicates medical treatment
- physician's evaluation that the patient cannot tolerate project inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fecal microbiota transplantation, Fidaxomicin, Vancomycin
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
FidaxomicinDrug
Fidaxomicin 200 mg x 2 daily for 10 days
VancomycinDrug
Vancomycin 125 mg x 4 daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor Receives: Other: Fecal microbiota transplantation |
| Fidaxomicin | Active comparator | 10 days fidaxomicin 200 mg x 2 daily Receives: Drug: Fidaxomicin |
| Vancomycin | Active comparator | 10 days vancomycin 125 x 4 daily Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment
Measured: 8 weeks
Secondary outcomes (10)
Number of patients with clinical resolution 1 week after primary treatment
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 1 week after finishing allocated treatment
Measured: 1 week
Number of patients with clinical resolution 8 weeks after primary treatment
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 8 weeks
Number of patients with clinical resolution 26 weeks after primary treatment
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 26 weeks
Number of patients with microbiological resolution week 1
Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 1 week
Number of patients with microbiological resolution week 8
Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 8 weeks
Number of patients with microbiological resolution week 26
Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 26 weeks
Number of patients with global resolution (Clinical and microbiological resolution) week 1
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 1 week after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 1 week
Number of patients with global resolution (Clinical and microbiological resolution) week 26
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Measured: 26 weeks
Numerical change in quality of life (EQ5D-3L) week 8 and 26
EQ5D-3L (www.euroqol.com) measures self-reported quality of life in 5 dimensions (each three levels), rendering score from 5 (lowest and best) to 15 (highest and worst) plus an overall reporting of general well being (0, lowest, worst to 100, highest, best). Scoring is obtained week 0,8,26 after randomization. Numerical changes are documented and compared using non-parametric statistics
Measured: 8 and 26 weeks
Microbiota pattern changes 1, 8 and 26 weeks
Microbiota profiling, 16S rRNA, absence or presence of specific genera
Measured: 1, 8 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens F Dahlerup, MD DrMSc, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743234
- Sponsor's protocol ID
- FACIT
- Acronym
- FACIT
- Status last verified
- Oct 2019
- First submitted
- 8 Apr 2016
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hammeken LH, Baunwall SMD, Dahlerup JF, Hvas CL, Ehlers LH. Health-related quality of life in patients with recurrent Clostridioides difficile infections. Ther Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.
PubMed 35463939Hvas 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.
PubMed 30610862
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02743234
- Acronym / sponsor ID
- FACIT / FACIT
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 19 Apr 2016 (estimated)
- 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.
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Other: Fecal microbiota transplantationFecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor |
| Fidaxomicin | Active comparator | Drug: Fidaxomicin10 days fidaxomicin 200 mg x 2 daily |
| Vancomycin | Active comparator | Drug: Vancomycin10 days vancomycin 125 x 4 daily |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Does not speak or understand the Danish language
- Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
- fulminant colitis which contraindicates medical treatment
- physician's evaluation that the patient cannot tolerate project inclusion
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 transplantationFMT follows 4-10 days of vancomycin 125 mg x 4 daily | Other | FMT |
| FidaxomicinFidaxomicin 200 mg x 2 daily for 10 days | Drug | Fidaxomicin |
| VancomycinVancomycin 125 mg x 4 daily for 10 days | Drug | Vancomycin |
Primary outcome
Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
Time frame: 8 weeks
Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment
10 secondary outcomes
Number of patients with clinical resolution 1 week after primary treatment
Time frame: 1 week
Number of patients with clinical resolution 8 weeks after primary treatment
Time frame: 8 weeks
Number of patients with clinical resolution 26 weeks after primary treatment
Time frame: 26 weeks
Number of patients with microbiological resolution week 1
Time frame: 1 week
Number of patients with microbiological resolution week 8
Time frame: 8 weeks
Number of patients with microbiological resolution week 26
Time frame: 26 weeks
Number of patients with global resolution (Clinical and microbiological resolution) week 1
Time frame: 1 week
Number of patients with global resolution (Clinical and microbiological resolution) week 26
Time frame: 26 weeks
Numerical change in quality of life (EQ5D-3L) week 8 and 26
Time frame: 8 and 26 weeks
Microbiota pattern changes 1, 8 and 26 weeks
Time frame: 1, 8 and 26 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 15 Oct 2019.
- Derived from this study: PubMed 35463939Hammeken LH, Baunwall SMD, Dahlerup JF, Hvas CL, Ehlers LH. Health-related quality of life in patients with recurrent Clostridioides difficile infections. Ther Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.
- Derived from this study: PubMed 30610862Hvas 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.
- Individual participant dataSharing planned: No
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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.
Jens F Dahlerup, MD DrMSc principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal microbiota transplantation, Fidaxomicin and Vancomycin in people with Clostridium 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 1 inclusion and 5 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 15 Oct 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment (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 NCT02743234, which also lists 2 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 15 Oct 2019.