Clostridium DifficilePhase 3NCT02801656
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
A Phase 3 study testing Fecal Microbiota Transplantation and Vancomycin in people with Clostridium Difficile, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Fecal Microbiota Transplantation and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to 1 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- life expectancy > 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization
Who cannot join
- pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received >4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count <200, or any medical or non-medical condition considered by the investigator to preclude participation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Official title: Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.
Read the detailed description
Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.
- Conditions
- Clostridium Difficile
- Being tested
- Fecal Microbiota Transplantation, Vancomycin, Fecal Microbiota Transplantation Placebo, Vancomycin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
Also called Stool Transplant
Oral, encapsulated FMT
VancomycinDrug
Also called Vancocin
Vancomycin po 125 mg qid x 10 days
Fecal Microbiota Transplantation PlaceboBiological
Also called Stool Transplant Placebo
Matching placebo to FMT
Vancomycin PlaceboDrug
Also called Vancocin Placebo
Matching placebo to Vancomycin
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Oral, encapsulated fecal microbiota transplantation Receives: Biological: Fecal Microbiota Transplantation; Drug: Vancomycin Placebo |
| Vancomycin | Active comparator | 125 mg po qid x 10 days Receives: Drug: Vancomycin; Biological: Fecal Microbiota Transplantation Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Cure of diarrhea without recurrence in intention to treat population
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.
Measured: 56 days
Adverse Events
Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
Measured: 56 days
Secondary outcomes (4)
Efficacy: Cure of diarrhea without recurrence in a per protocol population
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.
Measured: 56 days
Efficacy: cure of diarrhea in intention to treat and per protocol populations
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Measured: 10 days
Efficacy: time to cure of diarrhea
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Measured: 56 days
Efficacy: Health status questionnaire
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start1 Dec 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Daley, Memorial University of Newfoundland
- Investigators
- Peter Daley, MD FRCPC, Principal investigator, Memorial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801656
- Sponsor's protocol ID
- MUN-02
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2016
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After analysis is completed, data will be released
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02801656
- Acronym / sponsor ID
- MUN-02
- Conditions
- Clostridium Difficile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 16 Jun 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.
Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.
Detailed description
Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Biological: Fecal Microbiota Transplantation, Drug: Vancomycin PlaceboOral, encapsulated fecal microbiota transplantation |
| Vancomycin | Active comparator | Drug: Vancomycin, Biological: Fecal Microbiota Transplantation Placebo125 mg po qid x 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- life expectancy > 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization
Key exclusion criteria (1 listed)
- pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received >4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count <200, or any medical or non-medical condition considered by the investigator to preclude participation.
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 TransplantationAlso: Stool TransplantOral, encapsulated FMT | Biological | Fecal Microbiota Transplantation |
| VancomycinAlso: VancocinVancomycin po 125 mg qid x 10 days | Drug | Vancomycin |
| Fecal Microbiota Transplantation PlaceboAlso: Stool Transplant PlaceboMatching placebo to FMT | Biological | Vancomycin |
| Vancomycin PlaceboAlso: Vancocin PlaceboMatching placebo to Vancomycin | Drug | Fecal Microbiota Transplantation |
Primary outcome
Efficacy: Cure of diarrhea without recurrence in intention to treat population
Time frame: 56 days
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.
Adverse Events
Time frame: 56 days
Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
4 secondary outcomes
Efficacy: Cure of diarrhea without recurrence in a per protocol population
Time frame: 56 days
Efficacy: cure of diarrhea in intention to treat and per protocol populations
Time frame: 10 days
Efficacy: time to cure of diarrhea
Time frame: 56 days
Efficacy: Health status questionnaire
Time frame: 56 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Yes. After analysis is completed, data will be released
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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.
Peter Daley, MD FRCPC principal investigator
Memorial University
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 and Vancomycin in people with Clostridium Difficile, run by Memorial University of Newfoundland 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Apr 2022. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy: Cure of diarrhea without recurrence in intention to treat population (time frame: 56 days). The study lists 2 primary outcomes in all. 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 29 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.