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Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Primary Purpose

Bowel Movement Regulation, Occasional Constipation, Occasional Diarrhea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bacillus subtilis DE111®

About this trial

This is an interventional basic science trial for Bowel Movement Regulation focused on measuring Bowel movement regulation, Occasional constipation, Occasional diarrhea, Gastrointestinal health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kennesaw State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Bowel movement regularity

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

Tolerance

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04083521

First Posted

September 6, 2019

Last Updated

September 6, 2019

Sponsor

Deerland Enzymes

Collaborators

Kennesaw State University

1. Study Identification

Unique Protocol Identification Number

NCT04083521

Brief Title

Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

August 31, 2017 (Actual)

Study Completion Date

August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deerland Enzymes

Collaborators

Kennesaw State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bowel Movement Regulation, Occasional Constipation, Occasional Diarrhea

Keywords

Bowel movement regulation, Occasional constipation, Occasional diarrhea, Gastrointestinal health

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Bacillus subtilis DE111®

Intervention Description

Subjects were administered a dose of Bacillus subtilis at levels of 1x10^9 CFU once a day for 90-days.

Primary Outcome Measure Information:

Title

Bowel movement regularity

Description

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

Time Frame

105-day study period (consisting of 90-days treatment plus 15-day follow up)

Title

Tolerance

Description

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

Time Frame

105-day study period (consisting of 90-days treatment plus 15-day follow up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Kennesaw State University

City

Kennesaw

State/Province

Georgia

ZIP/Postal Code

30144

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

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