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Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections

NCT05606159 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-22

No results posted yet for this study

Summary

The purpose of this study is to determine whether a single strain capsulated probiotic, when used after standard C. difficile antibiotic therapy, is effective in reducing the risk of infection recurrence mediated by a decrease in colonization by toxigenic C. difficile. This study will include adults with a history of two episodes of C. difficile infection (CDI).

Conditions

  • Clostridium Difficile Infection Recurrence

Interventions

DIETARY_SUPPLEMENT

Bacillus velezensis DSM 33864

1 probiotic capsule to be taken orally once a day, with breakfast, once a day for 8 weeks.

DIETARY_SUPPLEMENT

Placebo

1 microcrystalline cellulose-containing placebo capsule to be taken orally once a day with breakfast, for 8 weeks.

Sponsors & Collaborators

  • Estimates OY

    collaborator UNKNOWN

  • Novozymes A/S

    lead INDUSTRY

Principal Investigators

  • Matthew Sims, PhD · Beaumont Hospital, Royal Oak. Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606159 on ClinicalTrials.gov