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Probiotic
Vancomycin vs Probiotics for Clostridium Difficile Infection (Decency-RCT Trial)
Phase < 1
Recruiting
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Decency-RCT Trial Summary
This trial is testing whether probiotics, vancomycin, or placebo can reduce C. difficile infection in hospitalized patients.
Who is the study for?
Adults over 18, colonized with C. difficile but not showing infection symptoms, who've started systemic antibiotics within the last 72 hours can join. They must have recent vital signs and blood tests recorded. Excluded are those allergic to study drugs or milk, pregnant/breastfeeding women, patients with certain heart diseases, hearing loss, severe kidney issues or on specific medications.Check my eligibility
What is being tested?
The trial is testing if taking Culturelle (a probiotic), oral Vancomycin (an antibiotic), or a placebo prevents C. difficile infection in hospitalized patients already carrying the bacteria but not infected. Participants will be randomly assigned to one of these three options in equal numbers.See study design
What are the potential side effects?
Possible side effects include digestive discomfort from probiotics and potential antibiotic-related issues like stomach upset for Vancomycin. Placebos typically have no active ingredients but can cause perceived side effects.
Decency-RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have started taking antibiotics for an infection.
Decency-RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Development of C difficile associated diarrhea within 14 days of randomization
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
Decency-RCT Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Vancomycin & probiotic placeboExperimental Treatment2 Interventions
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.
Group II: Probiotic & vancomycin placeboExperimental Treatment2 Interventions
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.
Group III: Probiotic placebo & vancomycin placeboPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Culturelle
2004
Completed Phase 1
~110
Vancomycin
FDA approved
Probiotic Placebo
2011
Completed Phase 4
~170
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,893 Total Patients Enrolled
1 Trials studying Clostridium Difficile
470 Patients Enrolled for Clostridium Difficile
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started taking antibiotics more than 3 days ago.You have had an allergic reaction to one of the study drugs or have a sensitivity to milk.My recent health checks and kidney function tests are up to date.I have a history of serious gut conditions like Crohn's disease or ulcerative colitis.I have a heart condition involving the walls of my heart chambers.I started taking probiotics or oral vancomycin in the hospital.I am pregnant, planning to become pregnant, or am breastfeeding.I am not taking aminoglycosides, ethacrynic acid, polymixin B, or colistin.I have experienced hearing loss before or am currently.I have started taking antibiotics for an infection.I have had diarrhea or fever/hypotension due to C. difficile infection.I have severe kidney disease with very low filtration rates.I am 18 or older and carry C. difficile without showing symptoms.I have a weakened immune system due to a condition like AIDS, cancer, long-term steroid use, or autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Probiotic placebo & vancomycin placebo
- Group 2: Vancomycin & probiotic placebo
- Group 3: Probiotic & vancomycin placebo
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What therapeutic indications are generally associated with Vancomycin?
"Vancomycin has proven to be an effective remedy for staphylococcal infections, enterocolitis caused by staphylococcus aureus, and other ailments stemming from the presence of this bacterium."
Answered by AI
Are individuals currently being recruited for this clinical experiment?
"Unfortunately, this trial is not actively seeking candidates at present. It was initially posted on September 1st 2022 and edited most recently on August 4th 2022. If you want to join another medical study, 109 trials are recruiting individuals with clostridium difficile colonization while 55 studies require participants infected by Vancomycin."
Answered by AI
Are there any other investigations that have focused on Vancomycin?
"Presently, there are 6 Vancomycin trials in Phase 3 with a total of 55 clinical studies. While numerous experiments take place in Jupiter, Florida; additional research centres can be found throughout the United States at 315 different sites."
Answered by AI
How many participants can take part in this research endeavor?
"This trial is no longer recruiting participants. It was first posted on September 1st 2022 and the most recent update was August 4th of the same year. However, if you are interested in similar studies, there are currently 109 investigations concerning clostridium difficile colonization and 55 trials for Vancomycin that require more individuals to complete their research."
Answered by AI
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