Recurrent Clostridium Difficile InfectionNCT03834038
Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection
A study testing Lyophilized Fecal Microbiota Transplantation in people with Recurrent Clostridium Difficile Infection, run by Vancouver Island Health Authority at 1 site in Canada.
Trial summary
The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Recurrent Clostridium Difficile Infection
- What is being tested?
- Lyophilized Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2015to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 years or older.
- Able to provide informed consent.
- Willing and able to comply with all the required study procedures.
- A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment unless patient taking treatment specifically for CDI for more than 3 months.
- History of at least ≥ 2 recurrent CDI where recurrence is defined as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy for each episode and/or ongoing symptoms consistent with CDI* (defined below) despite at least 7 days of treatment using oral vancomycin at a minimum dose of 250 mg four times daily.
- Symptoms of CDI include: diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea
Who cannot join
- Planned or actively taking another investigational product
- CDI symptom-free for 3 or more weeks following completion of CDI treatment
- Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
- Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
- Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
- Presence of colostomy
Show all 10Show fewer
- Unable to tolerate FMT or enema for any reason.
- Requiring systemic antibiotic therapy for more than 7 days.
- Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed
- Severe underlying disease such that the patient is not expected to survive for at least 30 days.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8
About this study
Official title: Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. Difficile Infection
The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.
Read the detailed description
Recurrence of CDI following a course of standard antibiotic therapy is high, especially in the elderly patients over 65 years of age, in hospitalized and in the immunocompromised patients. As CDI is characterized by intestinal dysbiosis. Fecal Microbiology Transplantation (FMT) has been investigated as alternative treatment for CDI and has been determined to be effective and safe. One of the major challenges of offering FMT is the availability of suitable donors. A donor may no longer be able to continue to donate for a number of reasons and this may lead to temporary interruption of FMT in centers which offer the program. In order to continue to offer FMT whenever needed, we will investigate the efficacy of lyophilized FMT. The lyophilization (freeze-drying) process works by dehydrating a frozen donor stool sample to complete dryness, using controlled temperature and pressure gradients. This lyophilized process results in a powdered form of the sample. Studies have shown that lyophilized donor stool samples have similar microbial compositions as the same fresh sample.The technique of freeze drying has been used for decades for the industrial storage of microbes and has been used. Preliminary study of lyophilized stool for FMT has been performed in dogs. Preliminary efficacy data in dogs with inflammatory bowel disease suggest equal efficacy as compared to fresh stool, although controlled study has yet to be performed. Should the lyophilized FMT (L-FMT) demonstrate to be equally or more effective than frozen FMT, there would be significant advantages. As with frozen FMT, lyophilized FMT will allow patients to receive FMT immediately as it can take up to two weeks for a donor's screening laboratory testing results to be available. Lyophilized FMT will also be more cost effective as less number of donors will need to be screened given the prolonged shelf life of lyophilized FMT which can be kept at above the freezing temperature. 9 This will also allow wider distribution and accessibility especially to the regions with limited capacity to manufacture FMT.
- Being tested
- Lyophilized 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.
Lyophilized Fecal Microbiota TransplantationDrug
Lyophilized FMT
| Study group | Role | What they receive |
|---|---|---|
| Open Label Lyophilized Fecal Microbiota Transplantation | Experimental | Eligible participants with history of recurrent or refractory CDI Receives: Drug: Lyophilized Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT
No recurrence of CDI-related diarrhea at 13 weeks following last FMT without the need for an intervention antibiotics or additional FMT specifically for CDI recurrence.
Measured: 13 weeks from last FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Oct 2015
- Primary completion1 Mar 2018
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Lee, Vancouver Island Health Authority
- Investigators
- Christine Lee, MD, Principal investigator, Vancouver Island Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834038
- Sponsor's protocol ID
- CDI.LYO.FMT
- Status last verified
- May 2024
- First submitted
- 6 Feb 2019
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. Difficile Infection
- ClinicalTrials.gov ID
- NCT03834038
- Acronym / sponsor ID
- CDI.LYO.FMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.
Detailed description
Recurrence of CDI following a course of standard antibiotic therapy is high, especially in the elderly patients over 65 years of age, in hospitalized and in the immunocompromised patients. As CDI is characterized by intestinal dysbiosis. Fecal Microbiology Transplantation (FMT) has been investigated as alternative treatment for CDI and has been determined to be effective and safe. One of the major challenges of offering FMT is the availability of suitable donors. A donor may no longer be able to continue to donate for a number of reasons and this may lead to temporary interruption of FMT in centers which offer the program. In order to continue to offer FMT whenever needed, we will investigate the efficacy of lyophilized FMT. The lyophilization (freeze-drying) process works by dehydrating a frozen donor stool sample to complete dryness, using controlled temperature and pressure gradients. This lyophilized process results in a powdered form of the sample. Studies have shown that lyophilized donor stool samples have similar microbial compositions as the same fresh sample.The technique of freeze drying has been used for decades for the industrial storage of microbes and has been used. Preliminary study of lyophilized stool for FMT has been performed in dogs. Preliminary efficacy data in dogs with inflammatory bowel disease suggest equal efficacy as compared to fresh stool, although controlled study has yet to be performed. Should the lyophilized FMT (L-FMT) demonstrate to be equally or more effective than frozen FMT, there would be significant advantages. As with frozen FMT, lyophilized FMT will allow patients to receive FMT immediately as it can take up to two weeks for a donor's screening laboratory testing results to be available. Lyophilized FMT will also be more cost effective as less number of donors will need to be screened given the prolonged shelf life of lyophilized FMT which can be kept at above the freezing temperature. 9 This will also allow wider distribution and accessibility especially to the regions with limited capacity to manufacture FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Lyophilized Fecal Microbiota Transplantation | Experimental | Drug: Lyophilized Fecal Microbiota TransplantationEligible participants with history of recurrent or refractory CDI |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 12 years or older.
- Able to provide informed consent.
- Willing and able to comply with all the required study procedures.
- A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment unless patient taking treatment specifically for CDI for more than 3 months.
- History of at least ≥ 2 recurrent CDI where recurrence is defined as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy for each episode and/or ongoing symptoms consistent with CDI* (defined below) despite at least 7 days of treatment using oral vancomycin at a minimum dose of 250 mg four times daily.
Key exclusion criteria (10 listed)
- Planned or actively taking another investigational product
- CDI symptom-free for 3 or more weeks following completion of CDI treatment
- Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
- Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
- Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
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 |
|---|---|---|
| Lyophilized Fecal Microbiota TransplantationLyophilized FMT | Drug | Open Label Lyophilized Fecal Microbiota Transplantation |
Primary outcome
No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT
Time frame: 13 weeks from last FMT
No recurrence of CDI-related diarrhea at 13 weeks following last FMT without the need for an intervention antibiotics or additional FMT specifically for CDI recurrence.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Recurrent Clostridium Difficile Infection
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
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Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
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ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
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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.
Christine Lee, MD principal investigator
Vancouver Island Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyophilized Fecal Microbiota Transplantation in people with Recurrent Clostridium Difficile Infection, run by Vancouver Island Health Authority at 1 site in Canada.
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 6 inclusion and 10 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 23 Sep 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 Canada. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT (time frame: 13 weeks from last FMT). 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 23 Sep 2024.