EnterocolitisPhase 2NCT03353506
Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection
A Phase 2 study testing LFMT and LSFF in people with Enterocolitis and Recurrent Clostridium Difficile Infection, run by Dina Kao at 1 site in Canada.
Trial summary
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterocolitis, Recurrent Clostridium Difficile Infection
- What is being tested?
- LFMT and LSFF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2018to 10 Oct 2019
- 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 toxin, each occurring within 3 months of each other.
- CDI 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 use effective contraception for the duration of the study as applicable
Who cannot join
- Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
- Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
- Taking or planning to take an investigational drug within 3 months of enrollment.
- Immunosuppression
- Chemotherapy or radiation therapy
- oropharyngeal or significant esophageal dysphagia
Show all 12Show fewer
- Ileus or small bowel obstruction
- Subtotal colectomy
- Pregnancy or planning to become pregnant within 3 months of enrollment
- Breastfeeding or planning to breastfeed during the trial
- Active infection requiring antibiotic therapy.
- Life expectancy <6 months -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
Read the detailed description
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
- Being tested
- LFMT, LSFF
- Medical subject headings
- Enterocolitis, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFMTBiological
Lyophilized fecal microbiota transplant
LSFFBiological
Lyophilized sterile fecal filtrate
| Study group | Role | What they receive |
|---|---|---|
| LFMT | Active comparator | Lyophilized fecal microbiota transplant capsules Receives: Biological: LFMT |
| LSFF | Experimental | Lyophilized sterile fecal filtrate capsules Receives: Biological: LSFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of RCDI
Proportion of subjects without RCDI
Measured: 8 weeks
Secondary outcomes (7)
Resolution of RCDI
Proportion of subjects 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 pain
Measured: 1 week
Difficulty in swallowing capsules
Reported by subjects as ranging between none, moderate or severe
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 posted27 Nov 2017
- Study start14 Feb 2018
- Primary completion5 Jun 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterocolitisStudies 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 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Kao
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Sponsor-investigator, Dina Kao, University of Alberta
- Investigators
- Dina Kao, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353506
- Sponsor's protocol ID
- Pro00076309
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
- ClinicalTrials.gov ID
- NCT03353506
- Acronym / sponsor ID
- Pro00076309
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Dina KaoUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 27 Nov 2017 (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) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
Detailed description
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
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: LFMTLyophilized fecal microbiota transplant capsules |
| LSFF | Experimental | Biological: LSFFLyophilized 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 toxin, each occurring within 3 months of each other.
- CDI 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 use effective contraception for the duration of the study as applicable
Key exclusion criteria (12 listed)
- Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
- Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
- Taking or planning to take an investigational drug within 3 months of enrollment.
- Immunosuppression
- Chemotherapy or radiation therapy
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 |
|---|---|---|
| LFMTLyophilized fecal microbiota transplant | Biological | LFMT |
| LSFFLyophilized sterile fecal filtrate | Biological | LSFF |
Primary outcome
Resolution of RCDI
Time frame: 8 weeks
Proportion of subjects without RCDI
7 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 in swallowing capsules
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 20 Feb 2020.
- 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.
Dina Kao, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LFMT and LSFF in people with Enterocolitis and Recurrent Clostridium Difficile Infection, run by Dina Kao 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 4 inclusion and 12 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 20 Feb 2020. 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.
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?
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 20 Feb 2020.