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

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

Study Overview

• Status: Completed
• Conditions: Bowel Movement Regulation; Occasional Constipation; Occasional Diarrhea
• Intervention / Treatment: Dietary supplement: Bacillus subtilis DE111®

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Kennesaw State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel movement regularity	Increasing regularity of bowel movements in subjects with occasional diarrhea or constipation	105-day study period (consisting of 90-days treatment plus 15-day follow up)
Tolerance	To determine if the supplement is tolerable among subjects without causing adverse events	105-day study period (consisting of 90-days treatment plus 15-day follow up)

Collaborators and Investigators

• Sponsor: Deerland Enzymes
• Collaborators: Kennesaw State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Gastrointestinal health; Bowel movement regulation; Occasional constipation; Occasional diarrhea
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Constipation
• Other Study ID Numbers: DE111Reg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No