Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Inf… (NCT05606159) | Clinical Trial Compass
WithdrawnNot Applicable
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
Stopped: Research Project closed
United States0Started 2023-11
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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