Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Sponsor

Deerland Enzymes (Industry)

Overall Status

Completed

CT.gov ID

NCT04083521

Collaborator

Kennesaw State University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bowel Movement Regulation Occasional Constipation Occasional Diarrhea	Dietary Supplement: Bacillus subtilis DE111®	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Aug 31, 2017

Actual Study Completion Date :

Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Subjects received a once daily dose of Bacillus subtilis DE111® 1x10^9 CFU for 90-days.	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.
No Intervention: Placebo Subjects received a once daily dose of maltodextrin for 90-days.

Arm

Intervention/Treatment

Experimental: Treatment

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

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.

No Intervention: Placebo

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.