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

NCT ID: NCT05606159

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Bacillus velezensis DSM 33864

This arm will receive a single strain probiotic capsule containing Bacillus velezensis DSM 33864.

The probiotic will be taken orally, once a day, for 8 weeks.

Group Type: EXPERIMENTAL

Bacillus velezensis DSM 33864

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo control group

A placebo capsule containing microcrystalline cellulose will be taken orally, once a day, for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Bacillus velezensis DSM 33864

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Probiotic

Eligibility Criteria

Inclusion Criteria

1. Males and females ≥ 18 years old

2. Medical record documentation of second or subsequent recurrent CDI episode, and received standard-of-care oral antibiotic therapy completed no more than 5 days prior date of enrollment.

3. Able to provide signed and dated informed consent or assent

4. Able to provide blood and fecal specimens

Exclusion Criteria

1. Current episode of CDI or delayed symptom resolution from previous reoccurrence (second episode), according to the physical exam and investigator assessment

2. Pregnancy or breastfeeding

3. Subjects presenting with active diarrhea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7

4. Taking dietary supplement or therapeutic intervention which could significantly affect parameter(s) followed during the study (fibers, probiotics, prebiotics, symbiotic) according to the investigator or stopped in a too short period before the V1 visit (< 4 weeks)

5. Previous reaction, including anaphylaxis, to any substance in composition of the study product

6. Active, non-controlled intestinal disease such as Crohn's Disease, ulcerative colitis; celiac disease, or other chronic diarrheal illness

7. Patients with active Pancreatitis

8. Ostomized subjects, parenteral nutrition users

9. Under immunosuppressive therapy or any health condition causing immunosuppression (including active hematological malignancies, acquired immune deficiency syndrome (AIDS), recent solid organ transplant (within 90 days),under treatment for rejection

10. For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded);

11. Pregnant or lactating women or intending to become pregnant within 3 months ahead

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Estimates OY

UNKNOWN

Sponsor Role: collaborator

Novozymes A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Sims, PhD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital, Royal Oak. Michigan

Locations

Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

NZ-GHCD-2021-06

Identifier Type: -

Identifier Source: org_study_id