Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients

NCT ID: NCT04246151

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-09-12

Brief 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. 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

Conditions

Clostridium Difficile Colonization; Clostridium Difficile Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Vancomycin & probiotic placebo

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 Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

Vancomycin capsules

Probiotic Placebo

Intervention Type: DRUG

sugar pill manufactured to mimic 10 billion unit probiotic capsules.

Probiotic & vancomycin placebo

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 Type: EXPERIMENTAL

Culturelle

Intervention Type: DIETARY_SUPPLEMENT

Culturelle capsules

Vancomycin Placebo

Intervention Type: DRUG

sugar pill manufactured to mimic the vancomycin 125 mg capsule

Probiotic placebo & vancomycin placebo

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.

Group Type: PLACEBO_COMPARATOR

Vancomycin Placebo

Intervention Type: DRUG

sugar pill manufactured to mimic the vancomycin 125 mg capsule

Probiotic Placebo

Intervention Type: DRUG

sugar pill manufactured to mimic 10 billion unit probiotic capsules.

Interventions

Vancomycin

Vancomycin capsules

Intervention Type: DRUG

Culturelle

Culturelle capsules

Intervention Type: DIETARY_SUPPLEMENT

Vancomycin Placebo

sugar pill manufactured to mimic the vancomycin 125 mg capsule

Intervention Type: DRUG

Probiotic Placebo

sugar pill manufactured to mimic 10 billion unit probiotic capsules.

Intervention Type: DRUG

Other Intervention Names

JAMP-vancomycin; Lactobacillus rhamnosus GG; Placebo for Vancomycin; Placebo for probiotic

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

DECENCY-RCT

Identifier Type: -

Identifier Source: org_study_id