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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clostridium Difficile Infection Recurrence
- Sponsor
- Novozymes A/S
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- C. difficile colonization
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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);
Outcomes
Primary Outcomes
C. difficile colonization
Time Frame: 8 weeks
Change in colonization (counts) of toxigenic C. difficile from baseline to 8 weeks determined by quantitative PCR
Secondary Outcomes
- C. difficile colonization(4 weeks)
- Presence and levels of C. difficile toxin in fecal samples(12 weeks)
- C.difficile colonization(12 weeks)
- Quality of life assessment(12 weeks)
- Reduction of the risk of rCDI(4 weeks)