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

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Hamilton Health Sciences Corporation

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

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.

Inclusion Criteria

I have started taking antibiotics for an infection.

Exclusion Criteria

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

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

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

I have experienced hearing loss before or am currently.

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

I started taking probiotics or oral vancomycin in the hospital.

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

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

I have severe kidney disease with very low filtration rates.

Treatment Details

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.

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.