Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Occasional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083521
• Other study ID #: DE111Reg
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2019
• Source: Deerland Enzymes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Movement Regulation
• Constipation
• Diarrhea
• Occasional Constipation
• Occasional Diarrhea

Intervention

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.

Locations

Country	Name	City	State
United States	Kennesaw State University	Kennesaw	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Deerland Enzymes	Kennesaw State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)