NCT04083521

Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Deerland Enzymes · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bowel Movement Regulation
• Occasional Constipation
• Occasional Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bacillus subtilis DE111®	Subjects were administered a dose of Bacillus subtilis at levels of 1x10\^9 CFU once a day for 90-days.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2019-09-10
• Last updated: 2019-09-10

Locations

1 site across 1 country: United States