NCT05606159

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

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Tolerability and Effect of Bacillus Velezensis DSM 33864 on the Reduction of Risk of Recurrent Clostridioides Difficile Infection (rCDI) in Adults With a History of rCDI

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novozymes A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

The goal of this multi-center randomized double-blinded placebo-controlled trial is to evaluate the tolerability and effect of a probiotic dietary supplement on the reduction of the risk of recurrent C. difficile infection in adults who have experienced two previous C. difficile infection episodes. The main aim of this study is to assess the effect of a probiotic dietary supplement on the colonization (cell counts) of C. difficile over time and also to assess the correlation between level of C. difficile colonization and recurrence of CDI. Approximately, 104 research subjects will be randomized into two arms and will use either one capsule daily of the probiotic supplement or placebo once daily with breakfast, for 8 weeks. All outcomes will be compared across the supplementation and placebo arm.

Conditions

• Clostridium Difficile Infection Recurrence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2022-11-04
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States