Bowel Movement Regulation, Occasional Constipation, Occasional Diarrhea
Conditions
Keywords
Bowel movement regulation, Occasional constipation, Occasional diarrhea, Gastrointestinal health
Brief summary
The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBacillus subtilis DE111®
Subjects were administered a dose of Bacillus subtilis at levels of 1x10\^9 CFU once a day for 90-days.
Sponsors
Kennesaw State University
Deerland Enzymes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants suffering from occasional constipation and/or diarrhea will be eligible for participation.
Exclusion criteria
* Blood CRP levels for each participant will be monitored at days 0, 60 and 105 of this study. Participants with CRP levels greater than 5mg/l on day 0 of the study will be excluded from further participation as this level is indicative of underlying inflammatory bowel disease. Participants excluded under such conditions will be instructed to seek further treatment with their health care provider.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movement regularity | 105-day study period (consisting of 90-days treatment plus 15-day follow up) | Increasing regularity of bowel movements in subjects with occasional diarrhea or constipation |
| Tolerance | 105-day study period (consisting of 90-days treatment plus 15-day follow up) | To determine if the supplement is tolerable among subjects without causing adverse events |
Countries
United States
Outcome results
None listed