Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Not Applicable

Completed

• Conditions: Bowel Movement Regulation; Occasional Constipation; Occasional Diarrhea
• Interventions: Dietary Supplement: Bacillus subtilis DE111®

• Registration Number: NCT04083521
• Lead Sponsor: Deerland Enzymes

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.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2019-09
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Kennesaw State University; 🇺🇸 Kennesaw, Georgia, United States