Recurrent C. Difficile InfectionZINFMTNCT06669936
Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection
An observational study of Recurrent C. Difficile Infection, run by Alexander Khoruts at 1 site in United States.
Trial summary
The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Recurrent C. Difficile Infection
- What is being tested?
- Fecal microbiota transplantation ± bezlotoxumab
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 28 Oct 2024
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with history of recurrent C. difficile infection who suffered a relapse without a new antibiotic provocation within 90 days of FMT.
Who may be able to join
- Informed consent.
- Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation.
- Failure of standard antibiotic therapies prior to the initial FMT
Who cannot join
- Pregnancy.
- Class III or above heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Efficacy Fo Oral Capsule FMT Combined with Bezlotoxumab Following Initial Failure of FMT Alone
The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.
Read the detailed description
Initial failure of FMT in breaking the cycle of recurrent C. difficile infections is associated with a greater risk of subsequent failure. Previous analysis showed that FMT failure is associated with delayed repair of fecal microbiota at one week after administration. The hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second FMT.
- Conditions
- Recurrent C. Difficile Infection
- Being tested
- Fecal microbiota transplantation ± bezlotoxumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation ± bezlotoxumabDrug
Also called FMT; Zinplava
Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.
| Study group | Role | What they receive |
|---|---|---|
| Zinplava/FMT | Patients with recurrent C. difficile infections, who failed FMT. This cohort includes patients treated with a combination of bezlotoxumab (Zinplava) and 2nd FMT. Receives: Drug: Fecal microbiota transplantation ± bezlotoxumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical failure
Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 May 2018
- Primary completion1 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent C. 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
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Khoruts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Khoruts, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669936
- Sponsor's protocol ID
- FMTZinplava001
- Acronym
- ZINFMT
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: All relevant data are going to be published.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Fo Oral Capsule FMT Combined with Bezlotoxumab Following Initial Failure of FMT Alone
- ClinicalTrials.gov ID
- NCT06669936
- Acronym / sponsor ID
- ZINFMT / FMTZinplava001
- Conditions
- Recurrent C. Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexander KhorutsUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 1 Nov 2024 (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.
The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.
Detailed description
Initial failure of FMT in breaking the cycle of recurrent C. difficile infections is associated with a greater risk of subsequent failure. Previous analysis showed that FMT failure is associated with delayed repair of fecal microbiota at one week after administration. The hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second FMT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zinplava/FMT | – | Drug: Fecal microbiota transplantation ± bezlotoxumabPatients with recurrent C. difficile infections, who failed FMT. This cohort includes patients treated with a combination of bezlotoxumab (Zinplava) and 2nd FMT. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with history of recurrent C. difficile infection who suffered a relapse without a new antibiotic provocation within 90 days of FMT.
Key inclusion criteria (3 listed)
- Informed consent.
- Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation.
- Failure of standard antibiotic therapies prior to the initial FMT
Key exclusion criteria (2 listed)
- Pregnancy.
- Class III or above heart failure.
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 transplantation ± bezlotoxumabAlso: FMT; ZinplavaCo-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone. | Drug | Zinplava/FMT |
Primary outcome
Clinical failure
Time frame: 90 days
Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool.
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 1 Nov 2024.
- Individual participant dataSharing planned: Undecided. All relevant data are going to be published.
Related trials for Recurrent C. Difficile Infection
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
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LMN-201 for Prevention of C. Difficile Infection Recurrence
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recurrent C. Difficile Infection, run by Alexander Khoruts at 1 site in United States.
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 3 inclusion and 2 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 1 Nov 2024. 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 United States. 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?
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?
Clinical failure (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.