NCT03462459

Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

Detailed description

Many patients who have a CDI experience recurrent or relapsing symptoms. The investigators are studying whether vancomycin in low doses will help prevent further CDI episodes and how this therapy impacts patients' gastrointestinal microbiome and composition. Patients with a history of past CDI who are receiving antibiotics for a non-CDI condition will be invited to participate. Approximately half of the participants will receive a low-dose capsule of vancomycin and half will receive a placebo. Participants will continue taking the vancomycin/placebo for 5 days after their prescribed antibiotics end.

Conditions

• Recurrent Clostridium Difficile Infection
• Clostridium Difficile Infection
• CDI
• C.Difficile Diarrhea
• C. Diff Colitis
• C.Difficile Colitis

Interventions

Type	Name	Description
DRUG	Vancomycin	Vancomycin capsule, 125 mg
DRUG	Placebo	Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule

Timeline

• Start date: 2018-05-21
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2018-03-12
• Last updated: 2025-05-25
• Results posted: 2025-05-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study