The purpose of this study is to determine the efficacy of Bacillus subtilis DE111®
probiotic for regulation of bowel movements.

Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Bowel Movement Regulation

Occasional Constipation

Occasional Diarrhea

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.

Bacillus subtilis DE111®

The Effect of Bacillus Subtilis DE111® on the Daily Bowel Movement Profile for People With Occasional Gastrointestinal Irregularity

Increasing regularity of bowel movements in subjects with occasional diarrhea or
constipation

To determine if the supplement is tolerable among subjects without causing adverse events

Subjects received a once daily dose of Bacillus subtilis DE111® 1x10^9 CFU for 90-days.

Subjects received a once daily dose of maltodextrin for 90-days.

Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status