What side effects are associated with this type of intervention?

Probiotics, which help restore natural gut flora, are generally well-tolerated but can cause mild gastrointestinal symptoms such as gas and bloating, and in rare cases, infections in immunocompromised individuals. Oral vancomycin, which inhibits the growth of C. difficile, can cause nausea, abdominal pain, and a bitter taste, with long-term use potentially leading to vancomycin-resistant enterococci. Both treatments aim to manage C. difficile infections effectively but come with their own risk profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for Clostridium difficile infection (CDI). Oral vancomycin, which inhibits the growth of C. difficile, is a well-established treatment. Fidaxomicin, another antibiotic, has also been approved and is noted for its minimal impact on the gut microbiome. Probiotics, which aim to restore natural gut flora, are being studied for their potential benefits in CDI, although specific probiotic formulations have not yet received FDA approval for this indication. These treatments are part of a broader strategy to manage and prevent CDI, especially in patients at high risk of recurrence.

What other types of research exist?

Promising novel alternatives for Clostridium difficile patients include fidaxomicin, which is favored over vancomycin for recurrent CDI due to better clinical outcomes, and bezlotoxumab, an adjunctive therapy recommended for patients with prior CDI within the last six months.

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Probiotic

Vancomycin vs Probiotics for Clostridium Difficile Infection (Decency-RCT Trial)

Q: What is the mechanism of action of this treatment?

Probiotics restore the natural gut flora, which helps create an environment less conducive to C. difficile overgrowth, while oral vancomycin inhibits the growth of C. difficile by interfering with its cell wall synthesis, leading to bacterial cell death. These mechanisms are important for C. difficile patients as they help reduce infection recurrence and improve overall outcomes by addressing both the disruption of gut microbiota and the direct elimination of the pathogen.

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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial is testing probiotics and an antibiotic called vancomycin in hospitalized patients who have C. difficile bacteria in their gut and are starting antibiotics. The goal is to find the best way to prevent these patients from getting a C. difficile infection. Probiotics have been studied and shown promising effects in preventing Clostridium difficile-associated diarrhea (CDAD).

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have started taking antibiotics for an infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a weakened immune system due to a condition like AIDS, cancer, long-term steroid use, or autoimmune disease.

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I have a heart condition involving the walls of my heart chambers.

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I have a history of serious gut conditions like Crohn's disease or ulcerative colitis.

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I have experienced hearing loss before or am currently.

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I am pregnant, planning to become pregnant, or am breastfeeding.

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I started taking probiotics or oral vancomycin in the hospital.

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I am not taking aminoglycosides, ethacrynic acid, polymixin B, or colistin.

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I have had diarrhea or fever/hypotension due to C. difficile infection.

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I have severe kidney disease with very low filtration rates.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Probiotics restore the natural gut flora, which helps create an environment less conducive to C. difficile overgrowth, while oral vancomycin inhibits the growth of C. difficile by interfering with its cell wall synthesis, leading to bacterial cell death. These mechanisms are important for C. difficile patients as they help reduce infection recurrence and improve overall outcomes by addressing both the disruption of gut microbiota and the direct elimination of the pathogen.

A meta-analysis and systematic review on the effect of probiotics in acute diarrhea.