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

NCT05606159 | Withdrawn DMC

• 1 other identifier: NZ-GHCD-2021-06
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Clostridium Difficile Infection Recurrence

Keywords

Probiotic; Gastrointestinal Microbiota; C. difficile; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• C. difficile colonization

  Change in colonization (counts) of toxigenic C. difficile from baseline to 8 weeks determined by quantitative PCR

  8 weeks

Secondary Outcomes (6)

• C. difficile colonization

  4 weeks

• C.difficile colonization

  12 weeks

• Presence and levels of C. difficile toxin in fecal samples

  12 weeks

• Quality of life assessment

  12 weeks

• Reduction of the risk of rCDI

  8 weeks

Other Outcomes (14)

• Incidence of adverse events

  12 weeks

• Changes in hemoglobin concentration

  12 weeks

• Changes in blood platelet levels

  12 weeks

Study Arms (2)

Bacillus velezensis DSM 33864

EXPERIMENTAL

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.

Dietary Supplement: Bacillus velezensis DSM 33864

Placebo control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Bacillus velezensis DSM 33864 DIETARY_SUPPLEMENT

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

Also known as: Probiotic

Bacillus velezensis DSM 33864

Placebo DIETARY_SUPPLEMENT

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

Placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years old
• 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.
• Able to provide signed and dated informed consent or assent
• Able to provide blood and fecal specimens

You may not qualify if:

• Current episode of CDI or delayed symptom resolution from previous reoccurrence (second episode), according to the physical exam and investigator assessment
• Pregnancy or breastfeeding
• Subjects presenting with active diarrhea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7
• 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)
• Previous reaction, including anaphylaxis, to any substance in composition of the study product
• Active, non-controlled intestinal disease such as Crohn's Disease, ulcerative colitis; celiac disease, or other chronic diarrheal illness
• Patients with active Pancreatitis
• Ostomized subjects, parenteral nutrition users
• 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
• 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);
• Pregnant or lactating women or intending to become pregnant within 3 months ahead

Sponsors & Collaborators

• Novozymes A/S: lead
• Estimates OY: collaborator

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Matthew Sims, PhD

  Beaumont Hospital, Royal Oak. Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled multicenter clinical trial

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: November 4, 2022
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)