Clostridium Difficile ColonizationEarly Phase 1Decency-RCTNCT04246151
Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients
A Early Phase 1 study testing Vancomycin and Culturelle in people with Clostridium Difficile Colonization and Clostridium Difficile Diarrhea, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Colonization, Clostridium Difficile Diarrhea
- What is being tested?
- Vancomycin and Culturelle
- 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
- 2 sitesCanada
- Study dates
- 1 Sep 2022to 12 Sep 2024
- Phase
- Early Phase 1
- 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
- Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below)
- Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection
- Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment
Who cannot join
- On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are)
- Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection
- Any patients with contra-indications to probiotics or vancomycin:
- Immunosuppressed (primary or acquired immunodeficiency, including AIDS (defined as AIDS defining condition or cluster of differentiation 4 (CD4) nadir of <200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome)
- Structural heart disease (e.g. atrial septal defect, ventricular septal defect)
- Gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of Crohn's disease and ulcerative colitis)
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- Patients on systemic aminoglycosides, ethacrynic acid, polymixin B, or colistin.
- Prior or current hearing loss
- Female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding
- Patients with end-stage renal diseases defined as an estimated glomerular filtration rate of <15ml/min, or absence of a current estimated creatinine clearance
- History of an allergic reaction to one of the study drugs, or sensitivity to milk
- Patients started on probiotics or oral vancomycin while in hospital
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Hamilton Health Sciences
Hamilton, Ontario, L8V 1C3
About this study
Official title: Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT): A Randomized Controlled Pilot Trial
The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.
Read the detailed description
In this study, patients will be screened for C. difficile colonization
- Being tested
- Vancomycin, Culturelle, Vancomycin Placebo, Probiotic Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called JAMP-vancomycin
Vancomycin capsules
CulturelleDietary supplement
Also called Lactobacillus rhamnosus GG
Culturelle capsules
Vancomycin PlaceboDrug
Also called Placebo for Vancomycin
sugar pill manufactured to mimic the vancomycin 125 mg capsule
Probiotic PlaceboDrug
Also called Placebo for probiotic
sugar pill manufactured to mimic 10 billion unit probiotic capsules.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin & probiotic placebo | Experimental | Vancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days. Receives: Drug: Vancomycin; Drug: Probiotic Placebo |
| Probiotic & vancomycin placebo | Experimental | Culturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days. Receives: Dietary Supplement: Culturelle; Drug: Vancomycin Placebo |
| Probiotic placebo & vancomycin placebo | Placebo comparator | Vancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days. Receives: Drug: Vancomycin Placebo; Drug: Probiotic Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
Feasibility will be assessed using the following parameters:
Proportion of eligible participants screened that are randomized within 72 hours of antibiotic exposure (goal ≥ 90%)
- Proportion of participants receiving all doses of study medication (goal ≥ 90%)
- Proportion of participants with complete follow up at 14 days (goal ≥ 95%)
Measured: 1 year
Development of C difficile associated diarrhea within 14 days of randomization
Development of C difficile associated diarrhea within 14 days of randomization to one of the treatment arms as defined by the Provincial Infectious Diseases Advisory Committee (PIDAC)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Sep 2022
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Why it stopped: No patients enrolled. Identification of patients in allocated timeframe was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile ColonizationStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246151
- Sponsor's protocol ID
- DECENCY-RCT
- Acronym
- Decency-RCT
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2020
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with researchers that are not directly involved in this study. Overall data will be shared in the context of peer reviewed journal publications or scientific presentations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT): A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04246151
- Acronym / sponsor ID
- Decency-RCT / DECENCY-RCT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled. Identification of patients in allocated timeframe was not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 29 Jan 2020 (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 of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.
Detailed description
In this study, patients will be screened for C. difficile colonization
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Patients will be randomized to receive either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design.
| Arm | Type | Receives |
|---|---|---|
| Vancomycin & probiotic placebo | Experimental | Drug: Vancomycin, Drug: Probiotic PlaceboVancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days. |
| Probiotic & vancomycin placebo | Experimental | Dietary Supplement: Culturelle, Drug: Vancomycin PlaceboCulturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days. |
| Probiotic placebo & vancomycin placebo | Placebo comparator | Drug: Vancomycin Placebo, Drug: Probiotic PlaceboVancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below)
- Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection
- Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment
Key exclusion criteria (12 listed)
- On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are)
- Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection
- Any patients with contra-indications to probiotics or vancomycin:
- Patients started on probiotics or oral vancomycin while in hospital
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 |
|---|---|---|
| VancomycinAlso: JAMP-vancomycinVancomycin capsules | Drug | Vancomycin & probiotic placebo |
| CulturelleAlso: Lactobacillus rhamnosus GGCulturelle capsules | Dietary supplement | Probiotic & vancomycin placebo |
| Vancomycin PlaceboAlso: Placebo for Vancomycinsugar pill manufactured to mimic the vancomycin 125 mg capsule | Drug | Probiotic & vancomycin placebo, Probiotic placebo & vancomycin placebo |
| Probiotic PlaceboAlso: Placebo for probioticsugar pill manufactured to mimic 10 billion unit probiotic capsules. | Drug | Probiotic placebo & vancomycin placebo, Vancomycin & probiotic placebo |
Primary outcome
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
Time frame: 1 year
Feasibility will be assessed using the following parameters: Proportion of eligible participants screened that are randomized within 72 hours of antibiotic exposure (goal ≥ 90%) * Proportion of participants receiving all doses of study medication (goal ≥ 90%) * Proportion of participants with complete follow up at 14 days (goal ≥ 95%)
Development of C difficile associated diarrhea within 14 days of randomization
Time frame: 1 year
Development of C difficile associated diarrhea within 14 days of randomization to one of the treatment arms as defined by the Provincial Infectious Diseases Advisory Committee (PIDAC)
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 20 Feb 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared with researchers that are not directly involved in this study. Overall data will be shared in the context of peer reviewed journal publications or scientific presentations.
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Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vancomycin and Culturelle in people with Clostridium Difficile Colonization and Clostridium Difficile Diarrhea, run by Hamilton Health Sciences Corporation at 2 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 3 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: withdrawn, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic. (time frame: 1 year). 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 20 Feb 2025.