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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Clostridium Difficile Infection Recurrence

In brief

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).

Key facts

Study ID

NCT05606159

Run by

Novozymes A/S

People needed

0

Starts

2023-11-01

Expected to finish

2024-12-01

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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