The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.
The purpose of this study is to determine the efficacy of the probiotic B. subtilis DE111® for regulation of bowel movements. A single capsule containing 1 x 10\^9 CFU B. subtilis is to be consumed once a day per participant. 50 adults (18-65 years of age at the time of participation) suffering from occasional constipation and/or diarrhea will be enrolled. Participants will be double-blindly and randomly assigned to either the probiotic (Bacillus subtilis) or the placebo (maltodextrin) group. Efficacy will be assessed with participant-reported bowel movement (BM) records. As a secondary outcome, the study will provide further insight into the tolerance of the supplement. Tolerance will be assessed using a digestive health questionnaire and blood samples to analyze pertinent metabolic biomarkers. Participants will be asked to complete a daily dietary intake record as well. Prior to capsule consumption, participants will complete a two-week pre-testing phase in order to provide a more inclusive diagnostic baseline. This phase will consist of daily BM and dietary intake record keeping.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
Subjects were administered a dose of Bacillus subtilis at levels of 1x10\^9 CFU once a day for 90-days.
Kennesaw State University
Kennesaw, Georgia, United States
Bowel movement regularity
Increasing regularity of bowel movements in subjects with occasional diarrhea or constipation
Time frame: 105-day study period (consisting of 90-days treatment plus 15-day follow up)
Tolerance
To determine if the supplement is tolerable among subjects without causing adverse events
Time frame: 105-day study period (consisting of 90-days treatment plus 15-day follow up)
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