Clostridia Difficile ColitisPhase 2NCT03806803
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
A Phase 2 study testing Lyophilized fecal microbiota transplant and Lyophilized sterile fecal filtrate in people with Clostridia Difficile Colitis and Clostridium Difficile Diarrhea, run by University of Alberta at 5 sites in Canada.
Trial summary
Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridia Difficile Colitis, Clostridium Difficile Diarrhea
- What is being tested?
- Lyophilized fecal microbiota transplant and Lyophilized sterile fecal filtrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesCanada
- Study dates
- 21 Mar 2019to 12 Mar 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
- CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
- Ability to provide informed consent
- Females and males must agree to effective contraception for the duration of the study
Who cannot join
- Severe or fulminant colitis
- Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
- Those taking or planning to take an investigational drug within 3 months of enrollment
- Chemotherapy or radiation therapy
- Oropharyngeal or significant esophageal dysphagia
- Ileus or small bowel obstruction
Show all 10Show fewer
- Pregnant or planning to become pregnant within 3 months
- Breastfeeding or planning to breastfeed during the trial
- Active infection requiring antibiotics
- Life expectancy <6 months Those with history of total colectomy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University Of Calgary
Calgary, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8
Mcgill University Health Centre
Montreal, Quebec
University of British Columbia
Vancouver, British Columbia
University of British Columbia
Victoria, British Columbia, V8R 1J8
About this study
Official title: A Multicenter Double Blind Randomized Study Comparing the Efficacy of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplantation (FMT) in the Management of Recurrent Clostridioides Difficile Infection (CDI)
Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works.
Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups.
Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.
Read the detailed description
This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules.
Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.
- Being tested
- Lyophilized fecal microbiota transplant, Lyophilized sterile fecal filtrate
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized fecal microbiota transplantBiological
15 capsules
Lyophilized sterile fecal filtrateBiological
15 capsules
| Study group | Role | What they receive |
|---|---|---|
| LFMT | Active comparator | Lyophilized fecal microbiota transplant capsules Receives: Biological: Lyophilized fecal microbiota transplant |
| LSFF | Experimental | Lyophilized sterile fecal filtrate capsules Receives: Biological: Lyophilized sterile fecal filtrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of RCDI
Proportion of patients without RCDI
Measured: 8 weeks
Secondary outcomes (8)
Resolution of RCDI
Proportion of patients with sustained cure
Measured: 24 weeks
Serious Adverse Events
Mortality directly attributable to CDI or treatment
Measured: 8 weeks
Serious Adverse Events
Infection directly attributable to treatment
Measured: 8 weeks
Minor Adverse Events
Nausea
Measured: 1 week
Minor Adverse Events
Vomiting
Measured: 1 week
Minor Adverse Events
Abdominal discomfort
Measured: 1 week
Difficulty swallowing capsules
Reported by patients as ranging between none, moderate or severe
Measured: 1 week
Fever
Temperature of >37.8C
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start21 Mar 2019
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridia Difficile ColitisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, University of Calgary, McGill University
- Responsible party
- Sponsor
- Investigators
- Dina Kao, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806803
- Sponsor's protocol ID
- Pro00087406
- Status last verified
- Jun 2024
- First submitted
- 14 Jan 2019
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kao D, Wong K, Lee C, Steiner T, Franz R, McDougall C, Silva M, Schmidt TSB, Walter J, Loebenberg R, Monaghan TM, Giebelhaus RT, Harynuk JJ, Xu H, Yaskina M, MacDonald KV, Marshall DA, Louie T. Effects of lyophilised faecal filtrate compared with lyophilised donor stool on Clostridioides difficile recurrence: a multicentre, randomised, double-blinded, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Nov;10(11):986-997. doi: 10.1016/S2468-1253(25)00190-6. Epub 2025 Sep 22.
PubMed 40997843
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double Blind Randomized Study Comparing the Efficacy of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplantation (FMT) in the Management of Recurrent Clostridioides Difficile Infection (CDI)
- ClinicalTrials.gov ID
- NCT03806803
- Acronym / sponsor ID
- Pro00087406
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of British Columbia, University of Calgary, McGill University
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 16 Jan 2019 (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.
Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works.
Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups.
Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.
Detailed description
This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules.
Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized
| Arm | Type | Receives |
|---|---|---|
| LFMT | Active comparator | Biological: Lyophilized fecal microbiota transplantLyophilized fecal microbiota transplant capsules |
| LSFF | Experimental | Biological: Lyophilized sterile fecal filtrateLyophilized sterile fecal filtrate capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
- CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
- Ability to provide informed consent
- Females and males must agree to effective contraception for the duration of the study
Key exclusion criteria (10 listed)
- Severe or fulminant colitis
- Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
- Those taking or planning to take an investigational drug within 3 months of enrollment
- Chemotherapy or radiation therapy
- Oropharyngeal or significant esophageal dysphagia
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 transplant15 capsules | Biological | LFMT |
| Lyophilized sterile fecal filtrate15 capsules | Biological | LSFF |
Primary outcome
Resolution of RCDI
Time frame: 8 weeks
Proportion of patients without RCDI
8 secondary outcomes
Resolution of RCDI
Time frame: 24 weeks
Serious Adverse Events
Time frame: 8 weeks
Serious Adverse Events
Time frame: 8 weeks
Minor Adverse Events
Time frame: 1 week
Minor Adverse Events
Time frame: 1 week
Minor Adverse Events
Time frame: 1 week
Difficulty swallowing capsules
Time frame: 1 week
Fever
Time frame: 1 week
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 4 Jun 2024.
- Derived from this study: PubMed 40997843Kao D, Wong K, Lee C, Steiner T, Franz R, McDougall C, Silva M, Schmidt TSB, Walter J, Loebenberg R, Monaghan TM, Giebelhaus RT, Harynuk JJ, Xu H, Yaskina M, MacDonald KV, Marshall DA, Louie T. Effects of lyophilised faecal filtrate compared with lyophilised donor stool on Clostridioides difficile recurrence: a multicentre, randomised, double-blinded, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Nov;10(11):986-997. doi: 10.1016/S2468-1253(25)00190-6. Epub 2025 Sep 22.
- Individual participant dataSharing planned: No
Related trials for Clostridia Difficile Colitis
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile
RecruitingPhase 3
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Clostridia Difficile Colitis
RecruitingPhase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
Clostridium Difficile Colitis
RecruitingObservational study
Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis
Ulcerative Colitis
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.
Dina Kao, MD principal investigator
University of Alberta
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyophilized fecal microbiota transplant and Lyophilized sterile fecal filtrate in people with Clostridia Difficile Colitis and Clostridium Difficile Diarrhea, run by University of Alberta at 5 sites 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 4 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Resolution of RCDI (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 NCT03806803, which also lists 1 linked publication.
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 4 Jun 2024.