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

Last updated: May 7, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Completed

Phase

2

Condition

Gastroenteritis

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Vancomycin

Placebo

Clinical Study ID

NCT03462459
2017-0927
A534265
Protocol ver 6, 18 Nov 2020
1R01HS025713-01
SMPH/MEDICINE/INFECT DIS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to provide informed consent.

  • Willing to comply with all study procedures and be available for the duration of thestudy.

  • Documented diagnosis of at least one CDI within the last 180 days with treatmentcompleted.

  • Currently receiving systemic antibiotics for a non-CDI condition with anticipatedduration of no more than 2 weeks.

  • Females of childbearing potential must have a negative pregnancy test prior torandomization and agree to use adequate contraception prior to randomization, forthe duration of the study, and for 4 weeks following study completion.

  • Have received no more than 72 hours of non-CDI antibiotics.

Exclusion

Exclusion Criteria:

  • History of hypersensitivity or allergy to oral vancomycin.

  • Current use of oral vancomycin

  • Patients on concurrent treatment with metronidazole or tetracycline monotherapy forany indication

  • Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterialgastrointestinal infection cause by agents other than C. difficile (e.g. Salmonellasp.), toxic megacolon and/or known small bowel ileus.

  • Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.

  • Major gastrointestinal surgery within 3 months of enrollment (does not includeappendectomy or cholecystectomy).

  • Any history of total colectomy or bariatric surgery.

  • Unable or unwilling to fulfill study requirements.

  • Expected life expectancy < 6 months.

  • Patients enrolled in another clinical trial with investigational drugs within 30days prior to randomization.

  • Women who are pregnant or breast-feeding.

  • Any patient deemed not suitable for study participation at the discretion of thestudy investigator.

  • Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.

Study Design

Total Participants: 79
Treatment Group(s): 2
Primary Treatment: Vancomycin
Phase: 2
Study Start date:
May 21, 2018
Estimated Completion Date:
July 06, 2023

Study 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.

Connect with a study center

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Division of Gastroenterology & Hepatology, Mayo clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Wisconsin-Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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