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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
1 probiotic capsule to be taken orally once a day, with breakfast, once a day for 8 weeks.
1 microcrystalline cellulose-containing placebo capsule to be taken orally once a day with breakfast, for 8 weeks.
Beaumont Hospital
Royal Oak, Michigan, United States
C. difficile colonization
Change in colonization (counts) of toxigenic C. difficile from baseline to 8 weeks determined by quantitative PCR
Time frame: 8 weeks
C. difficile colonization
Change in colonization (counts) of toxigenic C. difficile determined by quantitative PCR
Time frame: 4 weeks
C.difficile colonization
Change in colonization (counts) of toxigenic C.difficile determined by quantitative PCR
Time frame: 12 weeks
Presence and levels of C. difficile toxin in fecal samples
Change in concentration of C. difficile Toxin A or B levels in fecal samples from baseline to week 4, week 8 and week 12 determined by enzyme immune assay method (EIA)
Time frame: 12 weeks
Quality of life assessment
Change in average health-related quality of life scores at baseline, week 8 and 12, determined by EQ-5D-5L questionnaire
Time frame: 12 weeks
Reduction of the risk of rCDI
Incidence of rCDI defined as an episode of diarrhea onset described by three or more unformed stools per 24 h as measured by the Bristol stool chart (types 5 to 7), and positive toxin assay result for C. difficile.
Time frame: 8 weeks
Reduction of the risk of rCDI
Incidence of rCDI defined as an episode of diarrhea onset described by three or more unformed stools per 24 h as measured by the Bristol stool chart (types 5 to 7), and positive toxin assay result for C. difficile.
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Time frame: 4 weeks